FDA and the drug industry conclude technical negotiations over the next iteration of the Prescription Drug User Fee Act, setting the stage for broader...
An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in pharmaceutical advertising spending on television a...
FDA publishes a final guidance to assist sponsors in submitting human factors information with medical device marketing applications to fit the FDA ri...
FDA publishes two final guidances on aspects of establishing bioequivalence.
Reps. Debbie Dingell and Rich McCormick say FDA should update its strategy for evaluating and identifying sepsis as a means to exclude inappropriate t...
FDA marks the 50th anniversary of the 1976 Medical Device Amendments by highlighting the laws lasting role in shaping the modern oversight of medical ...
FDA issues an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that could cause serious ...
FDA extends by three months its review timeline of a Beren Therapeutics NDA for adrabetadex for treating infantile-onset Niemann-Pick disease, Type C.
