FDA posts a draft guidance entitled E19 Optimization of Safety Data Collection.
FDA issues a draft guidance with recommendations on clinical investigations for prostate tissue ablation devices.
Federal Register notice: FDA is seeking comments on an information collection extension related to a guidance on Administrative Procedures for Clinica...
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.