A bipartisan group of House lawmakers introduce legislation to make more over-the-counter (OTC) medications available to patients.
FDA warns Indias Rxhomeo about CGMP violations in its production of finished pharmaceuticals.
FDA clears a Viveve Medical 510(k) for the companys next-generation Viveve 2.0 cryogen-cooled monopolar radiofrequency system for use in general surgi...
A Florida federal court issues an order that stops U.S. Stem Cell Clinic, of Weston, FL, and U.S. Stem Cell Inc., of Sunrise, FL, from manufacturing o...
CDER Office of New Drugs team leader Paul Phillips explains when research or commercial IND should be used in completing an FDA-1571.
FDA warns Akorn following an inspection at its Somerset, NJ, drug manufacturing facility.
FDA issues Acer Therapeutics a complete response letter on its NDA for Edsivo (celiprolol) for treating vascular Ehlers-Danlos syndrome (vEDS).
The House Energy and Commerce Committee asks for an FDA briefing on two opioid and fentanyl use and abuse issues.