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The FDA issued a warning letter to French vaccine maker Aventis Pasteur following a March inspection of the company’s Lyon, France, manufacturing facility that revealed capping defects in numerous lots of Thymoglobulin, which is indicated for the prevention and treatment of kidney transplant rejection.
The Global Harmonization Task Force (GHTF) has updated its guidance document on medical device labeling with new labeling rules for in vitro diagnostic products.
The FDA should apply the same risk/benefit decisions that have accelerated the approval of new cancer treatments to therapies for other serious degenerative disease states, according to Johnson & Johnson (J&J).
The FDA will impose a partial or complete clinical hold on studies involving human drugs and biologics in cases where a clinical investigator has committed serious violations of FDA regulations or submitted false data to the agency or trial sponsor.
The Global Harmonization Task Force (GHTF) has revamped its guidance document on medical device labeling to add requirements for in vitro diagnostic products.
Small manufacturers that submit premarket approval (PMA) applications to the FDA before formally qualifying as a small business under the Medical Device User Fee and Modernization Act (MDUFMA) will have to pay the full user fee for that application, according to a revamped guidance document issued by the agency Aug. 20.
The final version of the National Institutes of Health’s (NIH’s) plan to fight the obesity epidemic calls for a $400 million commitment this year and a $440 million commitment in 2005 to fund a multipronged approach that combines pharmacologic, surgical, behavioral and other medical antiobesity strategies.
To reduce costs and delays in the drug development process, the FDA should consider fundamentally redesigning the current clinical trial model, including allowing investigational drugs to go to market on a conditional basis, according to a clinical research group.
FDA officials confirmed last week that the agency is drafting guidance to address medical device security, particularly as it relates to software security patches.