Federal Register notice: FDA makes available a draft guidance on Patient-Focused Drug Development: Methods To Identify What Is Important to Patients....
FDA warns South Koreas Dermameal about CGMP violations in its role as a contract manufacturer of finished pharmaceuticals.
FDA awards a five-year contract that could be worth $220 million to Harvard Pilgrim Health Care Institute for the next phase of the Sentinel project.
FDA provides information about the Urgent/11 cybersecurity vulnerability that could affect medical devices.
Endo says it is withdrawing a 2017 suit against FDA over agency enforcement discretion in permitting bulk drug compounding of vasopressin because the ...
FDA warns Lupin about CGMP violations and deviations at one of its units that are similar to those found in other Lupin facilities in India.
FDA releases its latest batch of Warning Letters that includes Lupin Limited, Shanghai Institute of Pharmaceutical Industry, Dermameal, and Galt Pharm...
Heron Therapeutics resubmits an NDA for HTX-011, an investigational agent for managing postoperative pain.