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FDA issues a draft guidance on using PBPK analyses for some biopharmaceutics applications.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.
FDA says it has learned of three patients from one facility who were infected after undergoing cardiothoracic surgery involving the use of a CardioQui...
CBER director Peter Marks says vaccine makers already know data recommendations outlined in a proposed guidance currently on hold at the White House.