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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...

Device User Fee Activities Hurt by Covid Demands: Shuren

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CDRH director Jeff Shuren says the Center has seen its work load grow substantially under the Covid-19 pandemic, and its having a ...

Covid Guidance on Clinical Trials Revised

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FDA adds product disposal content to a question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical P...

FDA Updates Safety Alert on Endovascular Graft Systems

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FDA updates its 2019 safety communication on Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms...

Notice on Complex Generic Meetings Guidance Corrected

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Federal Register notice: FDA corrects an 11/25 notice on a guidance entitled Formal Meetings Between the Food and Drug Administrat...

Comments on Bladder Cancer Drug Development Guidance

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Two drug companies comment on an FDA draft guidance on developing drugs and biologics for adjuvant treatment of bladder cancer.