CDRH director Jeff Shuren says the Center has seen its work load grow substantially under the Covid-19 pandemic, and its having a negative impact on m...
FDA adds product disposal content to a question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical Products During Covid...
FDA updates its 2019 safety communication on Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms and the risks assoc...
Federal Register notice: FDA corrects an 11/25 notice on a guidance entitled Formal Meetings Between the Food and Drug Administration and Abbreviated ...
Two drug companies comment on an FDA draft guidance on developing drugs and biologics for adjuvant treatment of bladder cancer.
Genus asks a Maryland federal court to require FDA to withdraw its approval of Lannett Numbrino because Lannett made materially untrue statements in i...
FDA watchers speculate that former commissioner David Kessler and former principal deputy commissioner Joshua Sharfstein are top contenders for the ag...
Federal Register notice: FDA renews its Pharmacy Compounding Advisory Committee for an additional two years.