Federal Register notice: FDA renews the charter of its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two years.
The Medical Device Innovation Consortium publishes its framework on external evidence methods for medical devices based on input from FDA and other stakeholders.
FDA commissioner Robert Califf says the agency is considering asking Congress for additional authority to have the option of requiring drug sponsors in their NDAs to demonstrate their product’s superiority over drugs that are already on the market.
FDA lifts a clinical hold on Pfizer’s mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy.
Retired Ethicon quality engineer Eric Hinrichs says medical device project design teams must document all risk assessments and how the risks have been mitigated or eliminated.