FDA releases an FDA-483 with six observations from an inspection at Sun Pharmaceuticals Halol, India, manufacturing facility.
Federal Register proposed rule: FDA proposes to repeal a regulation that requires an FDA-approved NDA or ANDA for any drug product that is sterilized ...
Federal Register notice: FDA announces a 10/10 Oncologic Drugs Advisory Committee meeting to review a Celltrion BLA for a proposed biosimilar to Genen...
Federal Register notice: FDA announces a public workshop entitled Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatme...
FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren propose a digital health Center of Excellence.
FDA releases the FDA-483 with five observations from an inspection at Indias Live Pharmaceuticals.
FDA accepts for review a Sanofi and Regeneron Pharmaceuticals supplemental BLA for Praluent (alirocumab) to update the Prescribing Information to incl...
FDA grants Syntimmune an orphan drug designation for SYNT001 for treating pemphigus.