FDA Dings Drugmakers Over Missing Pediatric Studies

By Jeff Overley (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 requires certain new prescription medicines to be studied in children.

Congress in last year's user-fee...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!