FDA Review posts the Federal Register notices for the week ending 1/10/2020.
FDA releases a draft guidance on Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters Premarket Notification (510(k)) Submi...
FDA issues SCA Pharmaceuticals a six-observation Form 483 after a November inspection cited GMP issues at the drug outsourcing facility.
A year after Bayer stopped selling and distributing its Essure implantable contraceptive device, CDRH director Jeff Shuren says Bayer has repossessed ...
Federal Register notice: FDA announces a 2/4 public meeting entitled Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.
FDA grants Meissa Vaccines a fast track designation for MV-012-968, a vaccine for protection against respiratory syncytial virus infection.
FDA grants Reflow Medical a breakthrough device designation for the Temporary Spur Stent System, a novel retrievable stent technology intended for tre...