FDA Dings Drugmakers Over Missing Pediatric Studies

Law360, New York (December 5, 2013, 6:47 PM EST) -- The U.S. Food and Administration is widening its criticism of pharmaceutical companies that haven't completed mandatory post-approval studies of their products' safety and effectiveness in children, although Pfizer Inc. and others being targeted are describing good-faith efforts to comply.

FDA's admonishments — the latest of which was disclosed Wednesday — came in the form of noncompliance letters sent to drugmakers and posted on the agency’s website. They allege a failure to analyze products in accordance with the Pediatric Research Equity Act, which passed in 2003 and...
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