FDA says Cook Medical has recalled all unexpired lots of its transseptal needle and transseptal needle with catheter due to the presence of rust in or...
FDA authorizes Covid-19 vaccine booster doses for certain Moderna and Johnson & Johnson vaccinated individuals; it also authorizes available booster d...
The House passes Rep. Pallones bipartisan National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing legislation.
FDA sends Stealth BioTherapeutics a refuse to file letter on its NDA for elamipretide, a mitochondria-targeted therapy for treating Barth syndrome.
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Federal Register notice: FDA makes available a draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplificatio...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 ...