Federal Register notice: FDA makes available a final guidance entitled Technical Performance Assessment of Quantitative Imaging in Radiological Device...
FDA releases the FDA-483 with six observations from an inspection at Phoenix, AZ-based Central Admixture Pharmacy Services.
FDA accepts for review a Merck supplemental BLA seeking approval for Keytruda (pembrolizumab) for the adjuvant treatment of patients with Stage IB, II...
Five stakeholders recommend changes and clarifications to an FDA draft guidance on CAR-T cell product development.
Six stakeholders provide comments to FDA on the agencys docket on human gene therapy products incorporating human genome editing.
CDER researchers describe the increasing use of artificial intelligence/machine learning in drug development regulatory submissions.
CDER director Patrizia Cavazzoni puts a positive spin on drug inspections, user fee goals, and enforcement and compliance activities, notwithstanding ...
FDA approves a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) injection, indicated for chronic weight management in adult and pe...