Four stakeholders suggest ways FDA could improve a draft guidance on fit-for-use clinical outcome assessments.
FDA approves Bimeda Animal Healths SpectoGard (spectinomycin sulfate), the first generic copy of Pharmacia Animal Healths Adspec.
Writing in a medical journal, CDER researchers say manufacturing-related deficiencies contribute significantly to a low first-review-cycle approval ra...
Federal Register notice: FDA makes available a final guidance entitled Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (...
Federal Register notice: FDA makes available a draft guidance entitled Providing Over-the-Counter Monograph Submissions in Electronic Format.
Two Hyman, Phelps & McNamara attorneys caution that actions providers take in response to an FDA safety communication could be seen by a court as evid...
Covington attorneys say the Justice Department has signaled it remains interested in pursuing False Claims Act cases premised on violations of FDA reg...
FDA approves a Celltrion BLA for Vegzelma (bevacizumab-adcd), a biosimilar to Genentechs Avastin (bevacizumab), for treating six cancer types.
