FDA posts a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentation and semi-synthet...
FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators already approved by ...
FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its use in treating patients with relapsed or refractor...
U.S. Sen. Susan Collins (R-ME) uses a Senate hearing 4/16 to spotlight barriers to lower-cost drugs, pressing an expert witness on delays in bringing ...
FDA satellite laboratories branch director JaCinta Batson touts the value of the laboratories work in international mail facilities to stop illegal an...
FDA classifies a correction involving certain ventilators manufactured by Philips as a Class I recall, warning that continued use of the devices witho...
FDA seeks expansion of testosterone replacement therapy use, encouraging drugmakers to explore whether existing products could be approved to treat lo...
An Institute for Clinical and Economic Review white paper states the potential benefits and challenges of several policy changes that could strengthen...
