FDA launches a new pilot to offer more transparency with drug approval decisions, among other initiatives to help understand the agencys regulatory ac...
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 warns Australias Delta Laboratories about CGMP violations in its production of finished pharmaceuticals.
Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Policy Regarding Compliance Dates for Class I and Uncla...