FDA Review posts product approval summaries for the week ending 8/29/2014
FDA grants Miracor Medical a breakthrough device designation for its PiCSO Impulse System for treating ST-elevated myocardial infarction patients.
FDA clears a Drawbridge Health 510(k) for the OneDraw A1C Test System, which comprises the OneDraw Blood Collection Device and the OneDraw A1C Test.
Medline recalls its Primary Warmer Pack because it contains the recalled Vyaire Medical enFlow Disposable Cartridge.
Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to discuss chikungunya vaccine deve...
Former FDA commissioner Robert Califf says the Novartis Zolgensma data integrity case shows the need for a well-funded and staffed FDA able to exercis...
FDA principal deputy commissioner Amy Abernathy tells the National Coordinator for Health IT Interoperability Forum about FDA current and planned acti...
Altaire Pharmaceuticals recalls several veterinary ophthalmic drug products due to concerns about quality assurance controls at its manufacturing faci...