FDA warns Indias Srikem Laboratories about CGMP violations and data integrity issues in its manufacturing of active pharmaceutical ingredients.
FDA issues two guidances on GRASE determinations for OTC sunscreen products.
In its latest batch of Warning Letters, FDA cites NutriResearch, Pine Pharmaceuticals, Physician Therapeutics, Srikem Laboratories and Wockhardt.
FDA issues a guidance on agency thinking on quality agreements in contract manufacturing arrangements.
FDA says its activities in soliciting comment on bioequivalence testing methodologies are sufficient and no additional activities are needed.
President-elect Donald Trump meets with Indiana state health commissioner Jerome Adams, presumably as a candidate for HHS secretary or another health-...
Intarcia Therapeutics files an NDA for ITCA 650 (exenatide) for treating Type 2 diabetes.
Federal Register Notice: FDA determines the regulatory review period for Medtronics Core Valve System for patent extension purposes 1,194 days.