FDA warns International Hospital Products about Quality System violations in its manufacturing of bowel decompression tubes.
Five stakeholders comment on an FDA draft guidance on initiating a voluntary regulated product recall.
FDA approves an Amag Pharmaceuticals NDA for Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal...
Federal Register notice: FDA submits to OMB an information collection extension entitled Reporting Associated With New Animal Drug Applications (NADA)...
Federal Register notice: FDA posts a final guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Lab...
Federal Register notice: FDA schedules Allergenic Products Advisory Committee meeting to review Peanut [Arachis hypogaea] Allergen Powder manufactured...
Several U.S. House democrats introduce HR 3379, the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act, that would reduce the ...
FDA lifts a partial clinical hold on an AbbVie/Genentech Phase 3 CANOVA (M13-494) trial evaluating venetoclax for the investigational treatment of rel...