Federal Register notice: FDA makes available a draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectivenes...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FDA publishes a draft guidance with recommendations for establishing effectiveness for drugs intended to treat patients with interstitial cystitis/bla...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.
AdvaMed says that if Congress does not repeal the medical device tax before the end of the year, more than 20,000 industry jobs will be lost in the ne...
The Medical Information Working Group says FDA should incorporate principles from five recent Supreme Court free speech decisions into its considerati...