Sens. Markey and Warren reintroduce legislation to eliminate the medical device excise tax approved as part of the Affordable Care Act.
FDA warns Wuhan Chinese Moxibustion Technology about CGMP violations in its production of finished pharmaceuticals.
FDA says it is working to implement a GAO report recommendation calling for communication of plans to issue or revise product-specific guidances for c...
FDA proposes regulations covering internal agency supervisory review of some decisions on medical devices regulated by CDRH.
Public Citizens Michael Carome says Congress should pass legislation to enhance FDAs expanded access program rather than right-to-try legislation that...
FDA Review posts the Federal Register notices for the week ending 1/12/2018.
FDA expands the approved use of AstraZenecas Lynparza (olaparib tablets) to include treating patients with certain types of breast cancer that have me...
Federal Register notice: FDA determines that the regulatory review period for Uromedicas Proact Adjustable Continence Therapy For Men was 3,892 days.