FDA warns Canadas Cellex-C drug manufacturing firm about significant CGMP violations.
FDA warns the Philippines Skin Sciences Laboratory about CGMP violations in its production of misbranded unapproved new drugs.
FDA releases the FDA-483 issued following an inspection at Indias Biocon sterile drug manufacturer.
FDA announces a 9/18 public meeting to discuss topics related to the structured assessment of benefits and risks in drug regulatory decision-making.
FDA tells a U.S. fertility doctor he cant market his spindle nuclear transfer technique to help some women conceive.
FDA issues a draft guidance explaining its enforcement discretion for expiration dating of repackaged unit-dose solid oral dosage form drugs.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Industry: Cooperative Manufacturing Arrangemen...
Federal Register notice: FDA seeks comments on an information collection for Prescription Drug Advertisements.