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.
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...