Faced with running out of 10-digit codes, FDA proposes to move to a 12-digit format for national drug codes.
Three Syneos Health executives give FDA six ways to strengthen its guidances on clinical trial diversity.
CBER director Peter Marks urges a move to continuous manufacturing for vaccines to gain from lessons learned during Covid-19 vaccine development.
Two Tellus Clinical Research study coordinators in Florida plead guilty to falsifying clinical trial data.
FDA clears a BioCircuit Technologies 510(k) for its nerve repair device, Nerve Tape, a sutureless option for surgical repair of transected nerves.
Federal Register notice: FDA makes available a draft guidance entitled Human Prescription Drug and Biological Products Labeling for Dosing Based on W...
Federal Register notice: FDA has made available a draft guidance entitled Evaluation of Therapeutic Equivalence that explains how it evaluates generic...
FDA says it has cleared the Renuvion APR Handpiece for specific subcutaneous dermatological and esthetic procedures.