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FDA permits marketing of first system of mobile medical apps for continuous glucose monitoring

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

FDA approves a second vaccine to prevent serogroup B meningococcal disease

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.

FDA approves Natpara to control low blood calcium levels in patients with hypoparathyroidism

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

Second Turkish man sentenced for smuggling counterfeit cancer drugs

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

Summary Information for: Protégé GPS Self-Expanding Peripheral Stent System

Labeling, Approval Order, and Summary of Safety and Effectiveness for Protégé GPS Self-Expanding Peripheral Stent System (P060001S020).

Consumer Information on: 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

PMA Final Decisions for October 2014

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for October 2014.

What's New: Vaccines, Blood & Biologics RSS Feed

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2015

Evolving Data Mining System is Designed to Speed Identification of Adverse Events Following Vaccinations

Summary Basis for Regulatory Action (BLA/STN# 125300/226)

November 5, 2013 Approval Letter - Cervarix

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