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Research and Markets: FDA and FTC Dietary Supplements Promotion and Advertising Compliance Regulations Webinar

The "Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations" webinar has been added to ResearchAndMarkets.com's offering. This 2-hr webinar will review the FDA and ....

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2021 Year in Review: OPDP Enforcement Actions Involving Prescription and Biological Products | Faegre Drinker Biddle & Reath LLP

The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a total of six letters in 2021 four Untitled Letters and two Warning Letters to pharmaceutical. ....

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Update: Use Of Real-World Evidence In FDA Approvals And Product Promotion - Food, Drugs, Healthcare, Life Sciences

Update: Use Of Real-World Evidence In FDA Approvals And Product Promotion - Food, Drugs, Healthcare, Life Sciences
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Time's up: New enforcement era for regenerative medicines begins June 1 - CBER reiterates May 31 end for HCT/P compliance "grace period" – Clinical trials or regulatory approvals will be needed for these products going forward | Hogan Lovells

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On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative medicines with time to assess whether they needed to file an investigational new drug application (IND) or marketing application with FDA, will conclude at the end of the month. The decision comes as a surprise to some in the industry that speculated the agency may provide further reprieve due to challenges presented by the ongoing COVID-19 pandemic. However, others in the industry appear less surprised given the agency’s prior admonishment of unapproved regenerative medicine products marketed as COVID-19 treatments, which were called “uncontrolled experimental procedures” in a JAMA article by then-FDA Commissioner Stephen Hahn, M.D., and Dr. Marks in June 2020. ....

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Déjà Vu, We Have All Been Here Before: OPDP Issues Its Second Warning Letter in 2021 | Arnall Golden Gregory LLP

Déjà Vu, We Have All Been Here Before: OPDP Issues Its Second Warning Letter in 2021 | Arnall Golden Gregory LLP
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