Federal Register Final Rule; technical amendment: FDA amends certain medical device regulations to correct editorial issues, such as typographical err...
Endo agrees to extend for 180 days a stay in its suit against FDA over agency policy in compounding using bulk drug substances.
FDA panel members are divided on CLIA waivers for using glucose meters to measure blood glucose in capillary blood in patients receiving intensive med...
FDA releases the establishment inspection report from its 2017 inspection at the Celltrion Yeonsgu-go Plant 1 in Inchon, Korea.
FDA approves a W. L. Gore expanded indication for its Gore Cardioform Septal Occluder for patent foramen ovale (PFO) closure to prevent recurrent isch...
FDA orders its first-ever mandatory recall for contaminated food products containing kratom manufactured by Triangle Pharmaceuticals.
Drug companies ask the Supreme Court to determine whether consumers who say they lost money on prescription eye drops because the bottles dispense dru...
Federal Register notice: FDA withdraws approval of five NDAs because the drug products are no longer marketed.