Federal Register notice: FDA extends the comment period for an 8/2 notice on a draft guidance on testing and labeling medical devices for MRI safety.
FDA warns Chinas Yino, Inc., about significant CGMP deviations in its manufacturing of APIs.
FDA releases a summary of changes to seven REMS shown on the REMS Web site in July and August.
Federal Register notice: FDA releases final guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Pre...
FDA warns Costa Ricas Polimeros y Servicios about CGMP and other violations in its manufacturing of OTC drugs.
FDA releases its latest batch of Warning Letters that includes Balamurali K. Ambati, Haw Par Healthcare, Metuchen Pharmaceuticals, Polimeros y Servici...
An annual Gallup Work and Education poll shows the pharmaceutical industry is the most poorly regarded industry by Americans, falling below even the f...
FDA says a Tennessee federal judge entered a consent decree against two companies to prohibit them from distributing drugs, dietary supplements, or me...