Latest FDA News and Information
The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from... read more
The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
The U.S. Food and Drug Administration today approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people... read more
Today, the U.S. District Court of the Eastern District of Missouri sentenced Sabahhadin Akman, an owner of the Turkish firm Ozay Pharmaceuticals, to 30 months imprisonment and a $150,000 fine for... read more
Food and Drug Adminstration (FDA): CDRHNew
Added transcripts for Public Workshop - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8-9, 2015
The purpose of this workshop was to discuss FDA?s proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred... read more
Labeling, Approval Order, and Summary of Safety and Effectiveness for Protégé GPS Self-Expanding Peripheral Stent System (P060001S020).
The Protégé GPS Self-Expanding Peripheral Stent System (Protégé GPS) is a thin, flexible, metal mesh tube that is implanted in the arteries that supply... read more
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for October 2014.