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Despite a $78 million pretax charge related to the recent recall of its Taxus drug-eluting stent, Boston Scientific last week posted record second-quarter earnings.
The physician prescription requirement for at-home use of automatic external defibrillators (AEDs) could be lifted if the FDA follows the advice of its Circulatory System Devices Panel, which Thursday weighed the benefits of a proposed over-the-counter AED.
The potential market for Guidant’s cardiac resynchronization therapy defibrillators (CRT-D) could grow by approximately 40 percent if the FDA follows the lead of its Circulatory System Devices Panel, which voted Wednesday to recommend approval for expanded indications for the devices.
A drug industry task force has recommended that the use of radio-frequency tags to identify and track drug products at the individual item level be at the heart of a system to secure product integrity throughout the supply chain.
Postmarketing commitment studies are becoming increasingly important in the drug approval process in the U.S., and the FDA is requesting them more often, according to a recent study.
Citing GlaxoSmithKline (GSK) for false and misleading claims about three of its hepatitis vaccinations, as well as a non-GSK influenza vaccine, the FDA’s Center for Biologics Evaluation and Research (CBER) has issued a warning letter to the company.
In a guidance issued last week, the FDA said that in regulations and policy statements where the term "available therapy" is not defined, the phrase should be interpreted as therapy that is specified in the approved labeling of regulated products, with only rare exceptions.
A federal grand jury has indicted Metabolife International and its founder, alleging they lied to the FDA in statements about a weight-loss dietary supplement containing ephedra.