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Two drug companies comment on an FDA draft guidance on developing drugs and biologics for adjuvant treatment of bladder cancer.

Genus Seeks Court Order Against Lannetts Numbrino

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Genus asks a Maryland federal court to require FDA to withdraw its approval of Lannett Numbrino because Lannett made materially un...

Kessler, Sharfstein in the Running for FDA Top Post

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FDA watchers speculate that former commissioner David Kessler and former principal deputy commissioner Joshua Sharfstein are top c...

FDA Renews Pharmacy Compounding Advisory Panel

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Federal Register notice: FDA renews its Pharmacy Compounding Advisory Committee for an additional two years.

Groups Ask Agency, Research Funding

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Some 76 healthcare organizations call on congressional leaders to approve increased funding for FDA and other key health agencies ...

FDA Covid Test EUA Priorities Updated

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FDA updates Covid test FAQs with an explanation of current agency priorities for reviewing test EUA requests.