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...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.