FDA warns Magnolia Medical Technologies about Quality System regulation violations in its work as a specification developer for a blood collection sys...
Federal Register notice: FDA makes available a draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplificatio...
Federal Register proposed rule: FDA proposes to establish a regulatory category for over-the-counter hearing aids and to make related amendments to up...
The Utah federal court approves a permanent injunction sought by FDA preventing Grandmas Herbs and its owners from marketing dietary supplements that ...
FDA warns Sircle Laboratories about CGMP violations in its production of finished drugs.
FDA grants Akero Therapeutics a fast track designation for efruxifermin and its use in treating non-alcoholic steatohepatitis (NASH).
FDA issues for comment a proposed rule and draft guidance on OTC hearing aids and personal sound amplification devices.
Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions during January, February, and March.