Federal Register notice: FDA renews the charter of its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two years...
Federal Register notice: FDA makes available a final guidance entitled Providing Submissions in Electronic Format Postmarketing Safety Reports.
The Medical Device Innovation Consortium publishes its framework on external evidence methods for medical devices based on input from FDA and other st...
Simulations Plus completes an FDA-funded project for a model-integrated design for bioequivalence studies in long-acting injectable drugs.
FDA commissioner Robert Califf says the agency is considering asking Congress for additional authority to have the option of requiring drug sponsors ...
The Biotechnology Innovation Organization suggests ways for FDA to create a conceptual framework to inform decision-making for pediatric cancer drugs.
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.