A review of FDA inspection documents by the journal Science on the agencys clinical trial oversight during the past 11 years shows enforcement is ofte...
Seven former FDA commissioners call on the White House to let FDA do its scientific work without political interference.
FDA updates the SARS-CoV-2 reference panel comparative data.
FDA issues a draft guidance on using PBPK analyses for some biopharmaceutics applications.
Catalyst says it will appeal a Florida federal court ruling dismissing its case against FDA over orphan drug exclusivity for Firdapse.
Federal Register notice: FDA announces an amendment to a 10/22 Vaccines and Related Biological Products Advisory Committee meeting.
Federal Register notice: FDA announces a 10/6 public meeting entitled Patient-Focused Drug Development for Stimulant Use Disorder.
FDA launches its redesigned Sentinel Initiative Web site to increase organization and usability.