CDERs Office of Compliance (OC) says its priorities for 2022 include supporting FDAs Covid-19 response , reducing harm caused by opioid crisis, and im...
Moderna is asking FDA for an emergency use authorization for its Covid-19 vaccine in children aged 6 months to 6 years old.
Lilly says its investigational weight-loss drug tirzepatide met all endpoints in the 72-week SURMOUNT-1 trial.
FDA lifts a clinical hold on Pfizers mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrop...
Retired Ethicon quality engineer Eric Hinrichs says medical device project design teams must document all risk assessments and how the risks have been...
FDA updates its Digital Health Policies Web page to include new information from the Covid-19 public health emergency.
Federal Register notice: FDA determines that Abraxis Pharmaceuticals cupric sulfate injection was not withdrawn from sale for reasons of safety or eff...
Federal Register notice: FDA renews the charter of its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two years...