FDA approves an Elite Pharmaceuticals ANDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets).
Federal Register notice: FDA submits to OMB a new information collection entitled Survey of Current Manufacturing Practices for the Cosmetics Industry...
Federal Register notice: FDA seeks comments on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors...
FDA releases its latest batch of Warning Letters that include American Contract Systems, Product Packaging and Surmasis Pharmaceutical.
FDA posts questions and answers about the presence of suspected carcinogenic impurities in some generic versions of valsartan drug products.
FDA approves Novimmunes Gamifant (emapalumab) for treating pediatric and adult patients with primary hemophagocytic lymphohistiocytosis who have refra...
The Truth in Advertising watchdog group says that many major cancer centers use misleading testimonials touting atypical results in their promotional ...
FDA warns two companies selling dietary supplements containing tianeptine.