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Dear Reader, Thank buy propecia merck you for following the Me&MyDoctor blog. I'm writing to let you know we are moving the public health stories authored by Texas physicians, residents, and medical students, and patients to the Texas Medical Association's social media channels. Be sure to follow us on all our social media accounts (Facebook, Twitter, Instagram) as well as Texas Medicine Today to access these stories and more.

We look forward to seeing you there.Best, buy propecia merck Olivia Suarez Me&My Doctor EditorThis Sunday is Super Bowl Sunday. Millions of people will settle in to watch the big game, but hair loss treatment won’t be taking a football break. With variants of the propecia spreading and treatment distribution still in its early phases, the Centers for Disease Control and Prevention (CDC) is urging Americans to celebrate this year’s game in a safe, nontraditional way.Have you ever attended a Super Bowl party?.

Traditionally, millions of people watch the game in buy propecia merck large gatherings. However – no surprise – doctors and health care workers are strongly discouraging people from attending parties involving a lot of people in close contact with one another. That doesn’t mean you can’t still meet to watch the game.

Just like most events, the safest option is hosting a virtual party or gathering only with your live-in family/roommates. If you opt for a buy propecia merck virtual Super Bowl watch party, connect with friends via a text group or video chat. You can still don your favorite team’s logo or colors and make appetizers for the people you live with.

If you do throw a game-watching party in person, take your TV outside or display the game outside using a projector, and have people sit at least 6 feet apart – especially if they don’t live together. CDC developed a list of tips to make small gatherings safer buy propecia merck. If you’re lucky enough to be among the 25,000 or so fans going to the Super Bowl in Tampa, or if you’re attending another large Super Bowl event, you should take extra precautions to avoid getting sick.

Call the venue in advance or check online about the safety measures being taken. Arrive at the venue early to avoid crowds. And practice socially distancing at all times.

Gotta cheer?. Stomp, clap, or use noisemakers instead of yelling and cheering, to reduce transmission of droplets.

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But when it comes to financial planning and saving, women often face more challenges than men — making it propecia missed dose harder for Order zithromax without prescription them to adequately save for retirement. It’s important for women to recognize these barriers so that they can make informed choices about their money, especially as they near retirement age. Here are five facts about women and retirement to help women and their families better prepare for this important milestone.

1. Women are more likely to work part time — and less likely to have employer-sponsored retirement plans. In 2020, women who worked part time made up 30% of all female wage and salary workers.

In comparison, only 19% of men in wage and salary jobs worked part time. (These numbers are elevated because of the hair loss treatment propecia, but the gender difference existed prior to the propecia – and remains today.) And we know part-time jobs are less likely to offer retirement plans. 2.

Women take more time away from work to care for others. Women are typically the ones who step into the role of caregiver. Mothers are more likely than fathers to reduce their work hours to care for a child or family member.

Additionally, about 58% of long-term caregivers are female. More time away from work generally means less ability to save. 3.

Too few women save for retirement. More than half of women are not saving for retirement. If you are among them, know that saving in an employer’s retirement plan is the most effective way to save for your future.

And often the employer offers a matching contribution – that's free money!. A workplace plan is the easiest way to save, so take advantage when you can. 4.

Women live longer. On average, a 65-year-old woman can expect to live to age 86. That’s 21 years in retirement, and nearly 3 years longer than men.

This makes it extra important for women to build a sufficient retirement nest egg for themselves. 5. Older women are more likely to live in poverty.

For all these reasons and more, women typically are retired for a longer period of time than men and with fewer assets. Unfortunately, women age 65 or older are about 43% more likely than men to live on an income below the poverty level. And about 65% of the elderly poor are women.

Start small if you must, but start saving now!. To learn more about how women can prepare for retirement, register for our free upcoming webcast – “Helping Women Take the Mystery Out of Retirement Planning” – on Sept. 2 at 2p.m.

ET. Speakers from the Social Security Administration, the Center for Medicare and Medicaid Services, and the Administration for Community Living will join the U.S. Department of Labor’s Employee Benefits Security Administration and its Women’s Bureau.

You can also check out our resources on planning for retirement and meeting your savings goals to get started today. Editor’s note. The Employee Benefits Security Administration interprets and enforces ERISA, and works to ensure the security of the retirement, health, and other workplace-related benefits of America’s workers and their families.

The Women’s Bureau develops policies to improve job opportunities and working conditions for women, and advocates for their equality and economic security. Tiffany Boiman is the director of the Women’s Bureau’s Office of Policy and Programs. Follow the Women’s Bureau on Twitter at @WB_DOL.

Ali Khawar is the acting assistant secretary for employee benefits security.119 Introducing the new DEL Bulletin Webpage 2021-08-12 118 Notice of Publication - GUI-0050 2021-08-10 117 Health Canada transitions interim order to the FDR for importing, selling, and advertising drugs in relation to hair loss treatment 2021-08-05 116 Canada and European Union - Recognition of Good Manufacturing Practices Extra-Jurisdictional Inspection Outcomes 2021-07-07 115 Notice of Publication (GUI-0028 and GUI-0029) 2021-07-02 114 Notice of consultation for regulatory amendments supporting export-only drugs and transshipments 2021-06-18 113 Requirements to notify or report to Health Canada 2021-04-11 112 Consultation GUI-0074, process validation. Terminal sterilization processes for drugs 2021-05-03 111 Canada and European Union - Recognition of good manufacturing practices extra-jurisdictional inspection outcomes 2021-04-22 110 Veterinary antimicrobial sales reporting 2021-03-04 109 Changes to the drug establishment licence exemptions for hand sanitizers 2021-03-02 108 Reminder. Cost-benefit analysis survey on proposed regulations due March 1, 2021 2021-02-18 107 CETA Regulatory Cooperation Forum – Stakeholder debrief meeting, February 10, 2021 2021-02-01 106 Health Canada nitrosamines webinar, February 10, 2021 2021-01-15 105 Transition measures for exceptional importation interim order 2021-01-25 104 Invitation stakeholder information session on the allocation of drugs accessed via exceptional importation 2021-01-19 103 Nitrosamine update to market authorisation holders of human pharmaceutical, biological and radiopharmaceutical products 2020-12-16 102 Consultation on the recommendations for interoperability of track and trace systems for medicines 2020-12-15 101 Brexit.

Summary information for Canadian companies 2020-12-03 100 New interim order - Safeguarding the drug supply 2020-12-03 99 New hair loss treatment hold for certain DEL applications 2020-11-13 98 Health Canada is adding tools to help prevent and alleviate drug shortages related to the hair loss treatment propecia 2020-10-28 97 Notice of consultation (GUI-0026) 2020-10-07 96 Electronic issuance of pharmaceutical product and good manufacturing practices certificates 2020-10-01 95 New pathway to expedite the authorization for importing, selling and advertising of hair loss treatment drugs 2020-09-21 94 Notice of publication (GUI-0066 and GUI-0069) 2020-08-25 93 Notice of webinar (GUI-0069) 2020-08-13 92 Guidance. Importing and exporting health products for commercial use (GUI-0117) 2020-08-13 91 Extension revised to complete risk assessments for nitrosamine impurities 2020-08-10 90 Notice of publication (GUI-0005) 2020-08-20 89 Coming into force of regulatory amendments (CUSMA) (June 30, 2020) 2020-06-30 88 Enhanced guidance to support submission of proposals for inclusion on List of Drugs for Exceptional Import and Sale 2020-06-25 87 Updated question and answer document regarding nitrosamine impurities 2020-06-12 86 Guidance on transportation and storage considerations 2020-05-15 85 Requests for Information on additional supply of certain drugs used in the treatment of hair loss treatment 2020-04-22 84 Guidance on business impact mitigation and additional measures for operational relief amid hair loss treatment 2020-04-16 83 Health Canada hair loss treatment update for health product licence holders 2020-04-09 82 Health Canada is taking action to quickly respond to potential drug shortages during the hair loss treatment propecia 2020-04-06 81 Electronic issuance of drug establishment licences 2020-04-02 80 Revised drug establishment licences (DEL) guides and form 2020-04-01 79 Information to market authorization holders (MAHs) of human pharmaceutical products regarding nitrosamine impurities 2020-03-27 78 Health product inspections and licensing blog 2020-03-27 77 Health Canada alleviates confirmatory and identity testing requirements for certain low-risk non-prescription drugs 2020-03-26 76 Canada announces interim drug product testing measures for licensed importers 2020-03-23 75 Approach to management of hair loss treatment 2020-03-17 74 hair loss treatment disinfectants and hand sanitizers 2020-03-17 73 Cost associated with foreign on-site assessments 2020-03-06 72 Notice of consultation (Annex 1) 2020-02-20 71 Important reminders (environmental crisis hair loss) 2020-02-19 70 Notice of consultation - Annex 4 to the good manufacturing practices guide – Veterinary drugs (GUI-0012) 2020-02-19 69 Small business training session 2020-02-19 68 ALR webex links 2020-02-05 67 Health Canada stakeholder information webinar - Nitrosamines in pharmaceuticals, January 31, 2020 2020-01-24 66 Introduction of telecommunication tools during GMP inspections 2020-01-17 65 CETA Regulatory Cooperation Forum - Stakeholder debrief meeting, February 4, 2020 2020-01-16 64 Follow-up to letter to drug establishment licence (DEL) holders to inform them about steps to take to avoid nitrosamine impurities 2019-12-05 63 Notice of consultation PIC/S GMP guide 2019-12-02 62 Management of applications and performance for drug establishment licences (GUI-0127) 2019-11-29 61 Training sessions on revised guidance documents related to the Fees in Respect of Drugs and Medical Devices Order 2019-12-29 60 Canada-EU CETA Civil Society Forum call for participation 2019-11-06 59 Migration of drug establishment licence (DEL) API foreign building data to the DEL database 2019-11-06 58 Terms and conditions relating to angiotensin II receptor blockers (ARBs), known as “sartans” 2019-11-06 57 Letter to market authorization holders of human pharmaceutical products to inform on steps to take to avoid nitrosamine impurities 2019-11-06 56 Transition period for new DEL requirements for active pharmaceutical ingredients (API) for veterinary use 2019-11-05 55 Revised fees for drugs and medical devices 2019-05-17 54 Survey on Canadian drug exportation 2019-05-02 53 Certificate of pharmaceutical product &. Good manufacturing practice certificate annual fee increase 2019-04-10 52 Health Canada’s fees for drugs and medical devices 2019-04-01 51 Best practices for submitting drug establishment licence (DEL) applications 2019-03-22 50 Stakeholder webinar presentation on the expanded sunscreen pilot 2019-02-18 49 Annual licence review webinar presentation and recording 2019-01-30 48 Pause-the-clock proposal webinar presentation and recording 2019-01-26 47 Additional Information regarding the expanded sunscreen pilot 2019-01-22 46 Presentation and recording on GUI-0031 webinar 2019-01-11 45 Notice to stakeholders – Release of good manufacturing practices for active pharmaceutical ingredients (GUI-0104) for consultation 2018-12-31 44 DEL annual licence review webinar 2018-12-21 43 Notice of consultation GUI-0069 2018-12-20 42 Notifying Health Canada of foreign actions - Guidance document for industry 2018-12-19 41 Launch of the expanded sunscreen pilot 2018-11-29 40 Webinar stop-the-clock 2018-11-28 39 Notice of consultation GUI-0028 &.

GUI-0029 2018-11-21 38 Call of expression of interest 2018-11-14 37 Technical issue with the Drug &. Health Product Inspection Database 2018-11-07 36 Inclusion of API in Australia-Canada Mutual Recognition Agreement 2018-11-01 35 Pause-the-clock proposal for drug and medical device establishment licence applications 2018-10-18 34 Introducing new blog 2018-10-15 33 Important reminders – Hurricane Florence 2018-09-27 32 Health Minister announces access to a U.S.-approved epinephrine auto-injector 2018-09-04 31 Stakeholder engagement seminars (GUI-0001) 2018-09-04 30 Notice of publication – GUI-0071 2018-07-10 29 Notice of consultation – GUI-0071 2018-07-05 28 Licensing requirements for reclassified high-level disinfectants and sterilants as medical devices 2018-07-23 27 Webinar GUI-0001 2018-06-01 26 Revised fee proposal for drugs and medical devices 2018-05-25 25 Important notice to stakeholders regarding revisions of drug establishment licensing guidance documents and forms as a result of amendments to the Food and Drug Regulations 2018-05-22 24 Antimicrobial regulatory amendment webinars affecting veterinary drugs – Drug establishment licensing and good manufacturing practices requirements 2018-03-29 23 GUI-0031 webinar 2018-03-15 22 Notice of publication 2018-02-18 21 Antimicrobial regulator amendment webinars affecting veterinary drugs – Health Canada 2018-02-07 20 GUI-0080 2018-01-09 19 Notice of consultation 2017-12-22 18 Pilot for sunscreen products 2017-12-21 17 Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients 2017-11-29 16 Important reminders – Puerto Rico 2017-10-04 15 Importation of drugs for an urgent public health need 2017-07-05 14 Change to the Health Canada website 2017-06-08 13 Publication of Proposed Regulations Amending the Food and Drug Regulations (Vanessa’s Law) in Canada Gazette, Part I [2017-05-05] 2017-05-05 12 Publication of proposed regulations amending the Food and Drug Regulations (importation of drugs for an urgent public health need ) in Canada Gazette, Part I 2017-05-02 11 Certificate of pharmaceutical product and good manufacturing practice certificate annual fee increase 2017-03-31 10 Annual licence review product list 2017-02-03 9 Launch of the new pilot for sunscreen products 2017-01-27 8 Notice of consultation 2017-01-18 7 Implementation of a new pilot for sunscreens 2016-12-22 6 Reminder. Active pharmaceutical ingredient (API) application screening as of November 8, 2016 2016-11-08 5 Reminder.

Table B for active pharmaceutical ingredients (APIs) 2016-11-08 4 Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients 2016-11-04 3 Important notice to stakeholders regarding drug establishment licence applications submitted on portable storage devices 2016-09-20 2 Good manufacturing practices requirements for foreign buildings conducting activities in relation to active pharmaceutical ingredients destined for Canada or used to fabricate finished dosage forms destined for Canada 2016-08-04 1 Changes to the application process related to foreign buildings listed on drug establishment licences 2016-07-21MDEL Bulletin, June 24 2021, from the Medical Devices Compliance Program On this page Fees for Medical Device Establishment Licences (MDELs) We issue Medical Device Establishment Licences (MDELs) to. class I manufacturers importers or distributors of all device classes for human use in Canada The MDEL fee is a flat fee, regardless of when we receive your initial application. The same fee applies to applications for.

a new MDEL the reinstatement of a suspended MDEL the annual licence review (ALR) of an MDEL If you submit any of these applications, you must pay the MDEL fee when you receive an invoice. See Part 3, Division 2 of the Fees in Respect of Drugs and Medical Devices Order. Normally, we collect the MDEL fee before we review an application.

However, to help meet the demand for medical devices during the hair loss treatment propecia, we have been reviewing and processing MDEL applications before collecting the fees. As a result, some MDEL holders still haven't paid the fees for their 2020 initial MDEL application, despite multiple reminders. Authority to withhold services in case of non-payment As stated in the Food and Drug Act, Health Canada has the authority to withhold services, approvals, rights and/or privileges, if the fee for an MDEL application is not paid.

Non-payment of fees 30.64. The Minister may withdraw or withhold a service, the use of a facility, a regulatory process or approval or a product, right or privilege under this Act from any person who fails to pay the fee fixed for it under subsection 30.61(1). For more information, please refer to.

Cancellation of existing MDELs We will cancel MDELs for existing MDEL holders with outstanding fees for. initial applications or annual licence review applications If your establishment licence is cancelled, you are no longer authorized to conduct licensable activities (such as manufacturing, distributing or importing medical devices). You must stop licensable activities as soon as you receive your cancellation notice.

Resuming activities after MDEL cancellation To resume licensable activities, you must re-apply for a new establishment licence and pay the MDEL fee. See section 45 of the Medical Device Regulations. To find out how to re-apply for a MDEL, please refer to our Guidance on medical device establishment licensing (GUI-0016).

In line with the Compliance and Enforcement Policy (POL-0001), Health Canada monitors activities for compliance. If your MDEL has been cancelled, you may be subject to compliance and enforcement actions if you conduct non-compliant activities. If you have questions about a MDEL or the application process, please contact the Medical Device Establishment Licensing Unit at hc.mdel.questions.leim.sc@canada.ca.

If you have questions about invoicing and fees for an MDEL application, please contact the Cost Recovery Invoicing Unit at hc.criu-ufrc.sc@canada.ca.

*/Saving, especially for retirement, should start early and continue throughout buy propecia merck your image source lifetime. But when it comes to financial planning and saving, women often face more challenges than men — making it harder for them to adequately save for retirement. It’s important for women to recognize these barriers so that they can make informed choices about their money, especially as they near retirement age.

Here are five facts about women and retirement to buy propecia merck help women and their families better prepare for this important milestone. 1. Women are more likely to work part time — and less likely to have employer-sponsored retirement plans.

In 2020, women who worked buy propecia merck part time made up 30% of all female wage and salary workers. In comparison, only 19% of men in wage and salary jobs worked part time. (These numbers are elevated because of the hair loss treatment propecia, but the gender difference existed prior to the propecia – and remains today.) And we know part-time jobs are less likely to offer retirement plans.

2. Women take more time away from work to care for others. Women are typically the ones who step into the role of caregiver.

Mothers are more likely than fathers to reduce their work hours to care for a child or family member. Additionally, about 58% of long-term caregivers are female. More time away from work generally means less ability to save.

3. Too few women save for retirement. More than half of women are not saving for retirement.

If you are among them, know that saving in an employer’s retirement plan is the most effective way to save for your future. And often the employer offers a matching contribution – that's free money!. A workplace plan is the easiest way to save, so take advantage when you can.

4. Women live longer. On average, a 65-year-old woman can expect to live to age 86.

That’s 21 years in retirement, and nearly 3 years longer than men. This makes it extra important for women to build a sufficient retirement nest egg for themselves. 5.

Older women are more likely to live in poverty. For all these reasons and more, women typically are retired for a longer period of time than men and with fewer assets. Unfortunately, women age 65 or older are about 43% more likely than men to live on an income below the poverty level.

And about 65% of the elderly poor are women. Start small if you must, but start saving now!. To learn more about how women can prepare for retirement, register for our free upcoming webcast – “Helping Women Take the Mystery Out of Retirement Planning” – on Sept.

2 at 2p.m. ET. Speakers from the Social Security Administration, the Center for Medicare and Medicaid Services, and the Administration for Community Living will join the U.S.

Department of Labor’s Employee Benefits Security Administration and its Women’s Bureau. You can also check out our resources on planning for retirement and meeting your savings goals to get started today. Editor’s note.

The Employee Benefits Security Administration interprets and enforces ERISA, and works to ensure the security of the retirement, health, and other workplace-related benefits of America’s workers and their families. The Women’s Bureau develops policies to improve job opportunities and working conditions for women, and advocates for their equality and economic security. Tiffany Boiman is the director of the Women’s Bureau’s Office of Policy and Programs.

Follow the Women’s Bureau on Twitter at @WB_DOL. Ali Khawar is the acting assistant secretary for employee benefits security.119 Introducing the new DEL Bulletin Webpage 2021-08-12 118 Notice of Publication - GUI-0050 2021-08-10 117 Health Canada transitions interim order to the FDR for importing, selling, and advertising drugs in relation to hair loss treatment 2021-08-05 116 Canada and European Union - Recognition of Good Manufacturing Practices Extra-Jurisdictional Inspection Outcomes 2021-07-07 115 Notice of Publication (GUI-0028 and GUI-0029) 2021-07-02 114 Notice of consultation for regulatory amendments supporting export-only drugs and transshipments 2021-06-18 113 Requirements to notify or report to Health Canada 2021-04-11 112 Consultation GUI-0074, process validation. Terminal sterilization processes for drugs 2021-05-03 111 Canada and European Union - Recognition of good manufacturing practices extra-jurisdictional inspection outcomes 2021-04-22 110 Veterinary antimicrobial sales reporting 2021-03-04 109 Changes to the drug establishment licence exemptions for hand sanitizers 2021-03-02 108 Reminder.

Cost-benefit analysis survey on proposed regulations due March 1, 2021 2021-02-18 107 CETA Regulatory Cooperation Forum – Stakeholder debrief meeting, February 10, 2021 2021-02-01 106 Health Canada nitrosamines webinar, February 10, 2021 2021-01-15 105 Transition measures for exceptional importation interim order 2021-01-25 104 Invitation stakeholder information session on the allocation of drugs accessed via exceptional importation 2021-01-19 103 Nitrosamine update to market authorisation holders of human pharmaceutical, biological and radiopharmaceutical products 2020-12-16 102 Consultation on the recommendations for interoperability of track and trace systems for medicines 2020-12-15 101 Brexit. Summary information for Canadian companies 2020-12-03 100 New interim order - Safeguarding the drug supply 2020-12-03 99 New hair loss treatment hold for certain DEL applications 2020-11-13 98 Health Canada is adding tools to help prevent and alleviate drug shortages related to the hair loss treatment propecia 2020-10-28 97 Notice of consultation (GUI-0026) 2020-10-07 96 Electronic issuance of pharmaceutical product and good manufacturing practices certificates 2020-10-01 95 New pathway to expedite the authorization for importing, selling and advertising of hair loss treatment drugs 2020-09-21 94 Notice of publication (GUI-0066 and GUI-0069) 2020-08-25 93 Notice of webinar (GUI-0069) 2020-08-13 92 Guidance. Importing and exporting health products for commercial use (GUI-0117) 2020-08-13 91 Extension revised to complete risk assessments for nitrosamine impurities 2020-08-10 90 Notice of publication (GUI-0005) 2020-08-20 89 Coming into force of regulatory amendments (CUSMA) (June 30, 2020) 2020-06-30 88 Enhanced guidance to support submission of proposals for inclusion on List of Drugs for Exceptional Import and Sale 2020-06-25 87 Updated question and answer document regarding nitrosamine impurities 2020-06-12 86 Guidance on transportation and storage considerations 2020-05-15 85 Requests for Information on additional supply of certain drugs used in the treatment of hair loss treatment 2020-04-22 84 Guidance on business impact mitigation and additional measures for operational relief amid hair loss treatment 2020-04-16 83 Health Canada hair loss treatment update for health product licence holders 2020-04-09 82 Health Canada is taking action to quickly respond to potential drug shortages during the hair loss treatment propecia 2020-04-06 81 Electronic issuance of drug establishment licences 2020-04-02 80 Revised drug establishment licences (DEL) guides and form 2020-04-01 79 Information to market authorization holders (MAHs) of human pharmaceutical products regarding nitrosamine impurities 2020-03-27 78 Health product inspections and licensing blog 2020-03-27 77 Health Canada alleviates confirmatory and identity testing requirements for certain low-risk non-prescription drugs 2020-03-26 76 Canada announces interim drug product testing measures for licensed importers 2020-03-23 75 Approach to management of hair loss treatment 2020-03-17 74 hair loss treatment disinfectants and hand sanitizers 2020-03-17 73 Cost associated with foreign on-site assessments 2020-03-06 72 Notice of consultation (Annex 1) 2020-02-20 71 Important reminders (environmental crisis hair loss) 2020-02-19 70 Notice of consultation - Annex 4 to the good manufacturing practices guide – Veterinary drugs (GUI-0012) 2020-02-19 69 Small business training session 2020-02-19 68 ALR webex links 2020-02-05 67 Health Canada stakeholder information webinar - Nitrosamines in pharmaceuticals, January 31, 2020 2020-01-24 66 Introduction of telecommunication tools during GMP inspections 2020-01-17 65 CETA Regulatory Cooperation Forum - Stakeholder debrief meeting, February 4, 2020 2020-01-16 64 Follow-up to letter to drug establishment licence (DEL) holders to inform them about steps to take to avoid nitrosamine impurities 2019-12-05 63 Notice of consultation PIC/S GMP guide 2019-12-02 62 Management of applications and performance for drug establishment licences (GUI-0127) 2019-11-29 61 Training sessions on revised guidance documents related to the Fees in Respect of Drugs and Medical Devices Order 2019-12-29 60 Canada-EU CETA Civil Society Forum call for participation 2019-11-06 59 Migration of drug establishment licence (DEL) API foreign building data to the DEL database 2019-11-06 58 Terms and conditions relating to angiotensin II receptor blockers (ARBs), known as “sartans” 2019-11-06 57 Letter to market authorization holders of human pharmaceutical products to inform on steps to take to avoid nitrosamine impurities 2019-11-06 56 Transition period for new DEL requirements for active pharmaceutical ingredients (API) for veterinary use 2019-11-05 55 Revised fees for drugs and medical devices 2019-05-17 54 Survey on Canadian drug exportation 2019-05-02 53 Certificate of pharmaceutical product &.

Good manufacturing practice certificate annual fee increase 2019-04-10 52 Health Canada’s fees for drugs and medical devices 2019-04-01 51 Best practices for submitting drug establishment licence (DEL) applications 2019-03-22 50 Stakeholder webinar presentation on the expanded sunscreen pilot 2019-02-18 49 Annual licence review webinar presentation and recording 2019-01-30 48 Pause-the-clock proposal webinar presentation and recording 2019-01-26 47 Additional Information regarding the expanded sunscreen pilot 2019-01-22 46 Presentation and recording on GUI-0031 webinar 2019-01-11 45 Notice to stakeholders – Release of good manufacturing practices for active pharmaceutical ingredients (GUI-0104) for consultation 2018-12-31 44 DEL annual licence review webinar 2018-12-21 43 Notice of consultation GUI-0069 2018-12-20 42 Notifying Health Canada of foreign actions - Guidance document for industry 2018-12-19 41 Launch of the expanded sunscreen pilot 2018-11-29 40 Webinar stop-the-clock 2018-11-28 39 Notice of consultation GUI-0028 &. GUI-0029 2018-11-21 38 Call of expression of interest 2018-11-14 37 Technical issue with the Drug &. Health Product Inspection Database 2018-11-07 36 Inclusion of API in Australia-Canada Mutual Recognition Agreement 2018-11-01 35 Pause-the-clock proposal for drug and medical device establishment licence applications 2018-10-18 34 Introducing new blog 2018-10-15 33 Important reminders – Hurricane Florence 2018-09-27 32 Health Minister announces access to a U.S.-approved epinephrine auto-injector 2018-09-04 31 Stakeholder engagement seminars (GUI-0001) 2018-09-04 30 Notice of publication – GUI-0071 2018-07-10 29 Notice of consultation – GUI-0071 2018-07-05 28 Licensing requirements for reclassified high-level disinfectants and sterilants as medical devices 2018-07-23 27 Webinar GUI-0001 2018-06-01 26 Revised fee proposal for drugs and medical devices 2018-05-25 25 Important notice to stakeholders regarding revisions of drug establishment licensing guidance documents and forms as a result of amendments to the Food and Drug Regulations 2018-05-22 24 Antimicrobial regulatory amendment webinars affecting veterinary drugs – Drug establishment licensing and good manufacturing practices requirements 2018-03-29 23 GUI-0031 webinar 2018-03-15 22 Notice of publication 2018-02-18 21 Antimicrobial regulator amendment webinars affecting veterinary drugs – Health Canada 2018-02-07 20 GUI-0080 2018-01-09 19 Notice of consultation 2017-12-22 18 Pilot for sunscreen products 2017-12-21 17 Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients 2017-11-29 16 Important reminders – Puerto Rico 2017-10-04 15 Importation of drugs for an urgent public health need 2017-07-05 14 Change to the Health Canada website 2017-06-08 13 Publication of Proposed Regulations Amending the Food and Drug Regulations (Vanessa’s Law) in Canada Gazette, Part I [2017-05-05] 2017-05-05 12 Publication of proposed regulations amending the Food and Drug Regulations (importation of drugs for an urgent public health need ) in Canada Gazette, Part I 2017-05-02 11 Certificate of pharmaceutical product and good manufacturing practice certificate annual fee increase 2017-03-31 10 Annual licence review product list 2017-02-03 9 Launch of the new pilot for sunscreen products 2017-01-27 8 Notice of consultation 2017-01-18 7 Implementation of a new pilot for sunscreens 2016-12-22 6 Reminder.

Active pharmaceutical ingredient (API) application screening as of November 8, 2016 2016-11-08 5 Reminder. Table B for active pharmaceutical ingredients (APIs) 2016-11-08 4 Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients 2016-11-04 3 Important notice to stakeholders regarding drug establishment licence applications submitted on portable storage devices 2016-09-20 2 Good manufacturing practices requirements for foreign buildings conducting activities in relation to active pharmaceutical ingredients destined for Canada or used to fabricate finished dosage forms destined for Canada 2016-08-04 1 Changes to the application process related to foreign buildings listed on drug establishment licences 2016-07-21MDEL Bulletin, June 24 2021, from the Medical Devices Compliance Program On this page Fees for Medical Device Establishment Licences (MDELs) We issue Medical Device Establishment Licences (MDELs) to. class I manufacturers importers or distributors of all device classes for human use in Canada The MDEL fee is a flat fee, regardless of when we receive your initial application.

The same fee applies to applications for. a new MDEL the reinstatement of a suspended MDEL the annual licence review (ALR) of an MDEL If you submit any of these applications, you must pay the MDEL fee when you receive an invoice. See Part 3, Division 2 of the Fees in Respect of Drugs and Medical Devices Order.

Normally, we collect the MDEL fee before we review an application. However, to help meet the demand for medical devices during the hair loss treatment propecia, we have been reviewing and processing MDEL applications before collecting the fees. As a result, some MDEL holders still haven't paid the fees for their 2020 initial MDEL application, despite multiple reminders.

Authority to withhold services in case of non-payment As stated in the Food and Drug Act, Health Canada has the authority to withhold services, approvals, rights and/or privileges, if the fee for an MDEL application is not paid. Non-payment of fees 30.64. The Minister may withdraw or withhold a service, the use of a facility, a regulatory process or approval or a product, right or privilege under this Act from any person who fails to pay the fee fixed for it under subsection 30.61(1).

For more information, please refer to. Cancellation of existing MDELs We will cancel MDELs for existing MDEL holders with outstanding fees for. initial applications or annual licence review applications If your establishment licence is cancelled, you are no longer authorized to conduct licensable activities (such as manufacturing, distributing or importing medical devices).

You must stop licensable activities as soon as you receive your cancellation notice. Resuming activities after MDEL cancellation To resume licensable activities, you must re-apply for a new establishment licence and pay the MDEL fee. See section 45 of the Medical Device Regulations.

To find out how to re-apply for a MDEL, please refer to our Guidance on medical device establishment licensing (GUI-0016). In line with the Compliance and Enforcement Policy (POL-0001), Health Canada monitors activities for compliance. If your MDEL has been cancelled, you may be subject to compliance and enforcement actions if you conduct non-compliant activities.

If you have questions about a MDEL or the application process, please contact the Medical Device Establishment Licensing Unit at hc.mdel.questions.leim.sc@canada.ca.

What should my health care professional know before I take Propecia?

They need to know if you have any of these conditions:

  • if you are female (finasteride is not for use in women)
  • kidney disease or
  • liver disease
  • prostate cancer
  • an unusual or allergic reaction to finasteride, other medicines, foods, dyes, or preservatives

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Consider a scenario where, at the start of an appointment with a therapist, she explains to you that ‘the success of the therapy will depend on your own positive expectations, the respect and esteem Buy cheap cialis online that you have for me as a qualified health professional, the warm tone and empathic approach that I adopt towards you, how much does propecia cost without insurance and the trust that you place in me, during the course of treatment’. You might find this transparency about the therapeutic process to be refreshingly how much does propecia cost without insurance honest. You might, however, be surprised if this openness turned out to be an ethical obligation that she owed you. Yet, for how much does propecia cost without insurance some commentators, this ‘open’ approach to psychotherapy – where there is openness about the common factors that can explain the efficacy of the therapy –is required by ethical standards of informed consent and (more generally) respect for patient autonomy.In this edition of the Journal of Medical Ethics, Garson Leder formulates two responses to this type of ‘open therapy claim’.

That ‘….informed consent does not require the practitioners ‘go open’ about the therapeutic common factors in psychotherapy, and clarity about the mechanism of change shows us that…psychotherapy, as it is commonly practiced, is not deceptive…’.1 This edition also contains a comment by Charlotte Blease on Leder’s paper, and a response by Leder to Blease’s comment. All of which makes for an engaging exchange between a proponent how much does propecia cost without insurance of, and an opponent to, open therapy.The open therapy claim stems from ‘common factors findings in psychotherapy’, specifically, the consensus that there is a set of “common factors mediate some, and possibly most, of the ameliorative effects in psychotherapeutic interventions”.1 These factors include:client characteristics (eg, positive expectations and hope), therapist qualities (eg, the ability to cultivate positive client characteristics), change processes (eg, the acceptance of a theoretical rationale for the therapy on offer), treatment structure (eg, the delivery of concrete treatments and techniques) and therapeutic relationship (eg, the development of a working alliance between therapist and patient).1There are, therefore, common factors that help explain the efficacy of therapy that are incidental to the theory that grounds or explains the specific psychotherapeutic intervention. Since these incidental common factors – client characteristics, therapist qualities, and the therapeutic relationship – are necessary components to a sufficient understanding of the efficacy of psychotherapy, we can appreciate why proponents of open therapy want patients to be informed of these ‘incidental’ common factors that explain why therapy works (when it does work).Leder’s response to open therapy, is to differentiate between mechanisms of change and mediators of change. The mechanisms of change amount to ‘the reasons why change occurred or how change came about’ whereas the mediators are the ‘variables that are statistically correlated with this change’.1 In Leder’s example of cognitive therapy, he explains that where a therapist seeks to address maladaptive cognitions (ie, thoughts, beliefs, and assumptions), the therapist may adopt techniques of ‘identifying and challenging maladaptive thoughts and beliefs and training patients to challenge maladaptive patterns of thought (eg, all-or-nothing thinking, catastrophising, and overgeneralisation)’.1 In order to explain the therapy, the therapist may then make a ‘theory-specific claim’ about the intervention, that it ‘works by modifying maladaptive core beliefs’.1 Leder argues that, while it remains true that the incidental common factors also explain ‘how it works’, one is a mechanism for change (that needs to be explained to the patient), the others are mediators for how much does propecia cost without insurance the change.For Blease, this will not do.

Her concern is that, given the enormous difficulty in isolating and testing the ‘efficacy of the so-called specific factors of any psychological modality’, it entirely plausible that the important agents of change are the mediators themselves, and the mechanisms may even be immaterial to the efficacy of any given therapy.2 Which is why ‘ethicists have argued patients should know about them’.2 According to Blease, until basic research can ‘take up the baton’ and provide ‘a clear mechanistic explanation about how a treatment is effective’,2 psychotherapy should be open therapy.Leder’s response to the problem of isolating and testing the efficacy of therapeutic interventions is also call for openness. But it is an openness about the uncertainty that surrounds the therapeutic how much does propecia cost without insurance intervention (the mechanism) itself. Since ‘there is currently no consensus about mechanisms of change in psychotherapy’, Leder suggests that patients need to be informed that ‘the therapy on…is based on disputed theoretical foundations’ and that ‘theory-specific techniques are not necessary for healing’.3 At dispute, therefore, is how open should open therapy be. An openness about what we know about how how much does propecia cost without insurance the therapeutic intervention (the mechanism) works or an openness about what we know about how therapy (the mechanism and the mediators) works.Both Leder and Blease seem to agree on one thing, at least.

They agree on the question that needs to be answered. For them, how much does propecia cost without insurance it is the ‘how does the therapy work’ question. For Leder, the answer lies in the mechanisms of change (the specific psychotherapeutic intervention). For Blease, the how much does propecia cost without insurance answer must also include the mediators of change (the incidental common factors).

Answering this question is then equated with providing informed consent. Now, if ‘explaining efficacy’ amounts to ‘providing informed consent’ how much does propecia cost without insurance then Blease might be on strong ground. But there may be a baton that needs to be taken up by ethicists. To clarify whether satisfying the ethical requirement of informed consent is the same as, or differs from, a scientific explanation of a treatment’s efficacy.Ethics statementsPatient consent for publicationNot required.AbstractSeveral authors have how much does propecia cost without insurance recently argued that psychotherapy, as it is commonly practiced, is deceptive and undermines patients’ ability to give informed consent to treatment.

This ‘deception’ claim is based on the findings that some, and possibly most, of the ameliorative effects in psychotherapeutic interventions are mediated by therapeutic common factors shared by successful treatments (eg, expectancy effects and therapist effects), rather than because of theory-specific techniques. These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of psychotherapy have a duty to ‘go open’ to patients about the role of common factors how much does propecia cost without insurance in therapy (even if this risks negatively affecting the efficacy of treatment). To not ‘go open’ is supposed to unjustly restrict patients’ autonomy. This paper makes two related arguments against the ‘go open’ how much does propecia cost without insurance claim.

(1) While therapies ought to provide patients with sufficient information to make informed treatment decisions, informed consent does not require that practitioners ‘go open’ about therapeutic common factors in psychotherapy, and (2) clarity about the mechanisms of change in psychotherapy shows us that the common-factors findings are consistent with, rather than undermining of, the truth of many theory-specific forms of psychotherapy. Psychotherapy, as it is commonly practiced, is not how much does propecia cost without insurance deceptive and is not a placebo. The call to ‘go open’ should be resisted and may have serious detrimental effects on patients via the dissemination of a false view about how therapy works.psychotherapyinformed consentpaternalismethics.

Consider a scenario where, at the start of an appointment with a therapist, she explains to you that ‘the success of the therapy will depend on your own positive expectations, the respect and esteem that you have for me as a qualified health professional, the warm buy propecia merck tone and empathic approach that I adopt towards you, and the trust that you place in me, during the course of treatment’. You might find this transparency about the therapeutic process buy propecia merck to be refreshingly honest. You might, however, be surprised if this openness turned out to be an ethical obligation that she owed you.

Yet, for some commentators, this ‘open’ approach to psychotherapy – where there is openness about the common factors that buy propecia merck can explain the efficacy of the therapy –is required by ethical standards of informed consent and (more generally) respect for patient autonomy.In this edition of the Journal of Medical Ethics, Garson Leder formulates two responses to this type of ‘open therapy claim’. That ‘….informed consent does not require the practitioners ‘go open’ about the therapeutic common factors in psychotherapy, and clarity about the mechanism of change shows us that…psychotherapy, as it is commonly practiced, is not deceptive…’.1 This edition also contains a comment by Charlotte Blease on Leder’s paper, and a response by Leder to Blease’s comment. All of which makes for an engaging exchange between a proponent of, and an opponent to, open therapy.The open therapy claim stems from ‘common factors findings in psychotherapy’, specifically, the consensus that there buy propecia merck is a set of “common factors mediate some, and possibly most, of the ameliorative effects in psychotherapeutic interventions”.1 These factors include:client characteristics (eg, positive expectations and hope), therapist qualities (eg, the ability to cultivate positive client characteristics), change processes (eg, the acceptance of a theoretical rationale for the therapy on offer), treatment structure (eg, the delivery of concrete treatments and techniques) and therapeutic relationship (eg, the development of a working alliance between therapist and patient).1There are, therefore, common factors that help explain the efficacy of therapy that are incidental to the theory that grounds or explains the specific psychotherapeutic intervention.

Since these incidental common factors – client characteristics, therapist qualities, and the therapeutic relationship – are necessary components to a sufficient understanding of the efficacy of psychotherapy, we can appreciate why proponents of open therapy want patients to be informed of these ‘incidental’ common factors that explain why therapy works (when it does work).Leder’s response to open therapy, is to differentiate between mechanisms of change and mediators of change. The mechanisms of change amount to ‘the reasons why change occurred or how change came about’ whereas the mediators are the ‘variables that are statistically correlated with this change’.1 In Leder’s example of cognitive therapy, he explains that where a therapist seeks to address maladaptive cognitions (ie, thoughts, beliefs, and assumptions), the therapist may adopt techniques of ‘identifying and challenging maladaptive thoughts and beliefs and training patients to challenge maladaptive patterns of thought (eg, all-or-nothing thinking, catastrophising, and overgeneralisation)’.1 In order to explain the therapy, the therapist may then make a ‘theory-specific claim’ about the intervention, that it ‘works by modifying buy propecia merck maladaptive core beliefs’.1 Leder argues that, while it remains true that the incidental common factors also explain ‘how it works’, one is a mechanism for change (that needs to be explained to the patient), the others are mediators for the change.For Blease, this will not do. Her concern is that, given the enormous difficulty in isolating and testing the ‘efficacy of the so-called specific factors of any psychological modality’, it entirely plausible that the important agents of change are the mediators themselves, and the mechanisms may even be immaterial to the efficacy of any given therapy.2 Which is why ‘ethicists have argued patients should know about them’.2 According to Blease, until basic research can ‘take up the baton’ and provide ‘a clear mechanistic explanation about how a treatment is effective’,2 psychotherapy should be open therapy.Leder’s response to the problem of isolating and testing the efficacy of therapeutic interventions is also call for openness.

But it is an buy propecia merck openness about the uncertainty that surrounds the therapeutic intervention (the mechanism) itself. Since ‘there is currently no consensus about mechanisms of change in psychotherapy’, Leder suggests that patients need to be informed that ‘the therapy on…is based on disputed theoretical foundations’ and that ‘theory-specific techniques are not necessary for healing’.3 At dispute, therefore, is how open should open therapy be. An openness about what we know about how the therapeutic intervention (the mechanism) works or an openness about buy propecia merck what we know about how therapy (the mechanism and the mediators) works.Both Leder and Blease seem to agree on one thing, at least.

They agree on the question that needs to be answered. For them, it is the ‘how does the therapy work’ buy propecia merck question. For Leder, the answer lies in the mechanisms of change (the specific psychotherapeutic intervention).

For Blease, the buy propecia merck answer must also include the mediators of change (the incidental common factors). Answering this question is then equated with providing informed consent. Now, if ‘explaining efficacy’ amounts to ‘providing informed consent’ then buy propecia merck Blease might be on strong ground.

But there may be a baton that needs to be taken up by ethicists. To clarify whether satisfying the ethical requirement of informed consent is the same as, or differs from, a scientific explanation of a buy propecia merck treatment’s efficacy.Ethics statementsPatient consent for publicationNot required.AbstractSeveral authors have recently argued that psychotherapy, as it is commonly practiced, is deceptive and undermines patients’ ability to give informed consent to treatment. This ‘deception’ claim is based on the findings that some, and possibly most, of the ameliorative effects in psychotherapeutic interventions are mediated by therapeutic common factors shared by successful treatments (eg, expectancy effects and therapist effects), rather than because of theory-specific techniques.

These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of psychotherapy have a duty to ‘go open’ to patients about the role of common factors in therapy buy propecia merck (even if this risks negatively affecting the efficacy of treatment). To not ‘go open’ is supposed to unjustly restrict patients’ autonomy. This paper makes two buy propecia merck related arguments against the ‘go open’ claim.

(1) While therapies ought to provide patients with sufficient information to make informed treatment decisions, informed consent does not require that practitioners ‘go open’ about therapeutic common factors in psychotherapy, and (2) clarity about the mechanisms of change in psychotherapy shows us that the common-factors findings are consistent with, rather than undermining of, the truth of many theory-specific forms of psychotherapy. Psychotherapy, as it is buy propecia merck commonly practiced, is not deceptive and is not a placebo. The call to ‘go open’ should be resisted and may have serious detrimental effects on patients via the dissemination of a false view about how therapy works.psychotherapyinformed consentpaternalismethics.

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Health Catalyst's cloud-based data platform, DOS™, will enhance Twistle's automation by enabling richer data-driven patient interaction. The Twistle technology also enables will propecia grow hair back Health Catalyst's clinical, quality, and Life Sciences solutions, through established clinical pathways and patient communication channels."Twistle is a leading healthcare technology company committed to developing software that healthcare organizations and Life Science companies need to keep patients engaged in their healthcare," said Dan Burton, CEO of Health Catalyst. "Their efforts to improve patient outcomes and reduce the cost of care are deeply aligned with our mission to be the catalyst for massive, measurable, data-informed improvements. We're excited to welcome the Twistle team will propecia grow hair back to Health Catalyst and look forward to working together to enable healthcare organizations to achieve the promise of population health." "Health Catalyst's acquisition of Twistle highlights our belief that the most promising technology in healthcare is combining AI and data with 'digital endpoints' for patient services to deliver value. Twistle creates endpoints that, in our experience, make it simple for us to interact asynchronously with patients in smarter ways, meeting them where they are digitally, and give our care teams the time to be even better at what they do best—delivering great care," said Aaron Martin, managing general partner of Providence Ventures and chief digital officer of Providence.

"Combined with Health Catalyst's data will propecia grow hair back and analytics technology, we expect accelerated innovation in personalizing our outreach to patients," he added."The synergy between our cultures, values, and solutions will have a tremendous impact on the health and wellness of patients. Health Catalyst's patient insights can trigger personalized outreach, and the patient's unique profile will allow Twistle's communication pathways to adapt to their preferences and attributes in unprecedented ways. We are excited about the prospects of our joint solutions will propecia grow hair back proactively engaging at-risk populations, advancing health equity, and improving patient activation in their care," said Kulmeet Singh, founder and CEO of Twistle. "We anticipate that care teams will realize even more efficiency gains as our automated outreach will be more intelligent and individualized, freeing their time to focus on patients that require intervention to stay on track with their medical plan of care."Health Catalyst expects to fund the transaction using a mix of stock and cash. The parties expect the transaction, which is subject to customary closing conditions, to close in early Q3 will propecia grow hair back 2021.

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We anticipate that Twistle's leading clinical workflow and patient engagement platform, paired with the Health Catalyst population health buy propecia merck offering, will enable a comprehensive go-to-market solution to address the population health needs of healthcare organizations, as well as Life Science organizations, around the globe. Health Catalyst's cloud-based data platform, DOS™, will enhance Twistle's automation by enabling richer data-driven patient interaction. The Twistle buy propecia merck technology also enables Health Catalyst's clinical, quality, and Life Sciences solutions, through established clinical pathways and patient communication channels."Twistle is a leading healthcare technology company committed to developing software that healthcare organizations and Life Science companies need to keep patients engaged in their healthcare," said Dan Burton, CEO of Health Catalyst. "Their efforts to improve patient outcomes and reduce the cost of care are deeply aligned with our mission to be the catalyst for massive, measurable, data-informed improvements.

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We are buy propecia merck excited about the prospects of our joint solutions proactively engaging at-risk populations, advancing health equity, and improving patient activation in their care," said Kulmeet Singh, founder and CEO of Twistle. "We anticipate that care teams will realize even more efficiency gains as our automated outreach will be more intelligent and individualized, freeing their time to focus on patients that require intervention to stay on track with their medical plan of care."Health Catalyst expects to fund the transaction using a mix of stock and cash. The parties expect the transaction, which is subject to customary closing conditions, buy propecia merck to close in early Q3 2021. Further details regarding the acquisition will be reported on a Form 8-K filing that will be filed with the Securities and Exchange Commission today.About Health CatalystHealth Catalyst is a leading provider of data and analytics technology and services to healthcare organizations committed to being the catalyst for massive, measurable, data-informed healthcare improvement.

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Twistle integrates sophisticated automation with multi-channel communication, engaging patients through secure text messaging, interactive voice response, patient portals, or the health system's digital applications.Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements relating to expectations, plans, and prospects including expectations relating to our ability to close, and the timing of the buy propecia merck closing of, this transaction and the benefits that will be derived from this transaction. These forward-looking statements are based upon the current expectations and beliefs of Health Catalyst's management as of the date of this release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements including, without limitation, the risk of adverse and unpredictable macro-economic conditions and risks related to closing this transaction and integration of the companies. All forward-looking statements in this press release are based on information buy propecia merck available to the Company as of the date hereof, and Health Catalyst disclaims any obligation to update these forward-looking statements.Media Contact:Amanda Hundtamanda.hundt@healthcatalyst.com575-491-0974 View original content to download multimedia:http://www.prnewswire.com/news-releases/health-catalyst-announces-agreement-to-acquire-twistle-301319757.htmlSOURCE Health CatalystSALT LAKE CITY, May 28, 2021 (GLOBE NEWSWIRE) -- Health Catalyst, Inc. ("Health Catalyst", Nasdaq.

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