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FDA releases an FDA-483 with six observations from an inspection at Sun Pharmaceuticals Halol, India, manufacturing facility.[ Price : $8.95]
Federal Register proposed rule: FDA proposes to repeal a regulation that requires an FDA-approved NDA or ANDA for any drug product...[ Price : $8.95]
Federal Register notice: FDA announces a 10/10 Oncologic Drugs Advisory Committee meeting to review a Celltrion BLA for a proposed...[ Price : $8.95]
Federal Register notice: FDA announces a public workshop entitled Evidence-Based Treatment Decision in Transplantation: Patient In...[ Price : $8.95]
FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren propose a digital health Center of Excellence.[ Price : $8.95]
FDA releases the FDA-483 with five observations from an inspection at Indias Live Pharmaceuticals.[ Price : $8.95]
FDA accepts for review a Sanofi and Regeneron Pharmaceuticals supplemental BLA for Praluent (alirocumab) to update the Prescribing...[ Price : $8.95]
FDA grants Syntimmune an orphan drug designation for SYNT001 for treating pemphigus.