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FDA Faulted on Inspection Alternatives

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Former FDA Office of Compliance and Biologics Quality deputy director Mark I. Schwartz criticizes FDA for its slow response to the...

Feds Sue Firm Selling Unapproved Drugs

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The Justice Department files a civil complaint to stop AMARC Enterprises from distributing unapproved and misbranded drugs and adu...

Alert on Face Masks Containing Metal During MRI

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FDA issues a safety alert to warn patients and health care providers about patient injuries from wearing face masks that contain m...

Pilot on Innovative Drug Development Tools

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FDA details the launch of a new pilot program to provide a pathway for novel drug development tools to be used in regulatory appli...

Biden Taps CA Attorney General as HHS Secretary

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President-elect Joe Biden names California attorney general Xavier Becerra as his nominee for HHS secretary, a sign that an FDA co...

Guidance on Combination Product Feedback

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Federal Register notice: FDA makes available a final guidance entitled Requesting FDA Feedback on Combination Products.

Ensemble Orthopedics CMC Osteoarthritis Implant Cleared

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FDA clears an Ensemble Orthopedics 510(k) for its Ensemble CMC Implant for treating patients with early-stage osteoarthritis of th...

Labeling Changes for Merck Diabetes Drugs

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FDA approves labeling changes on Mercks Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (...

Protective Barrier Enclosures, Infusion Pump EUAs Revoked

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Federal Register notice: FDA announces the revocations of Emergency Use Authorizations issued to manufacturers of certain protecti...

FDA Moves Ahead on DTC Endorsements Research

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CDERs Office of Prescription Drug Promotion seeks approval to expanding on previous direct-to-consumer advertising research involv...