FDA posts a final guidance entitled Refuse to Accept Policy for 510(k)s that outlines the procedures and criteria the agency intends to use in assessi...
Biogen withdraws a European marketing authorization application for its troubled Alzheimers drug aducanumab.
FDA accepts for review a Revance Therapeutics BLA resubmission for DaxibotulinumtoxinA for Injection, indicated for treating moderate to severe glabel...
Federal Register notice: FDA withdraws six compliance policy guides because they contain duplicative information or they no longer reflects the agency...
FDA seeks comments from the pharmaceutical industry on its project to identify and prioritize pharmaceutical quality and chemistry and manufacturing a...
More than 65 scientific experts call on FDA to recommend that Covid-19 vaccine developers assess T-cells in addition to antibodies in vaccine trials.
Federal Register notice: FDA creates a docket to solicit public comments on a potential modification to its Opioid Analgesic Risk Evaluation and Mitig...
Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...