Genus calls on FDA to rescind its acceptance of a Lannett 505(b)(2) application for a cocaine hydrochloride product.
Several professional groups take issue with provisions in an FDA discussion paper on a benefit/risk approach for medical devices for weight loss.
Federal Register notice: FDA makes available a draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectivenes...
FDA clears an EmCyte 510(k) for its Progenikine Concentrating System for adipose lipoplasty.
FDA publishes a draft guidance with recommendations for establishing effectiveness for drugs intended to treat patients with interstitial cystitis/bla...
Federal Register notice: FDA establishes a docket to obtain information and comments that will assist it in determining whether to establish a pilot p...
A CDRH Industry Basics webcast gives basic program information on the 513(g) device determination and classification process and the custom device exe...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Spark Therapeutics Luxturna.