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The FDA is requesting postmarketing commitment studies more often, as they are becoming increasingly important in the drug approval process in the U.S., according to a recent study.
A pharmaceutical industry task force has recommended that the use of radio-frequency tags for identifying and tracking drug products at the individual item level be at the heart of a system to secure product integrity throughout the supply chain.
HHS’ Centers for Medicare & Medicaid Services (CMS) announced that it is revising its Medicare coverage policy to remove barriers that prevent antiobesity treatments from being covered.
Acting FDA Commissioner Lester Crawford made his first major appointment last week, naming Daniel Schultz director of the Center for Devices and Radiological Health (CDRH).
Clinical trial investigators are continuing to find themselves in hot water with the FDA, which last week released three new warning letters issued to medical device trial operators.
Bayer received an FDA warning letter last month following a facility inspection that revealed deficiencies in the manufacture of the Clinitek 50 urine chemistry analyzer, a diagnostic system that was the subject of a Class II recall in May 2003.
Boston Scientific did receive some positive news last week, as the FDA approved the firm’s investigational device exemption (IDE) filing to initiate the U.S. trial of its next-generation drug-eluting stent (DES) system, the Taxus Liberte.
Cordis recently found itself on the receiving end of an FDA warning letter for sponsor deficiencies discovered in a clinical trial of its Precise carotid stent, but company officials said they don’t expect the action to affect Precise’s pending premarket approval (PMA) application.