FDA clears a BioElectronics 510(k) for its over-the counter ActiPatch medical device and an expanded indication adjunctive treatment of musculoskelet...
FDA grants EyeYon Medical a breakthrough device designation for its EndoArt Artificial Endothelial Layer Implant.
Romark Laboratories asks FDA to require several bioequivalence tests for any ANDA citing Romarks Alinia as the reference-listed product.
FDA announces a 3/5 workshop on Advancing Animal Models for Antibacterial Drug Development.
Federal Register notice: FDA and the Federal Trade Commission announce a 3/9 public workshop: FDA/FTC Workshop on a Competitive Marketplace for Biosim...
FDA warns Balance of Nature that it is marketing dietary supplements that the agency considers to be unapproved and misbranded new drugs.
FDA warns South Koreas Won Industry Co. about Quality System and other violations in its manufacturing of the Morning Life Compression Limb Therapy Sy...
FDA issues a draft guidance on developing drugs to treat Sanfilippo syndrome.