FDA rules around pediatric drug trials have been tightening, to ensure more targeted data on drug efficacy and safety in children. Quintiles’ Dr. Edward Tabor traces the evolving US regulatory guidelines for pediatric studies in an article published in Regulatory Focus, the journal for the Regulatory Affairs Professionals Society. From early regulations allowing extrapolation to the recent Food and Drug Administration Amendments Act of 2007 (FDAAA), Dr. Tabor outlines the critical changes that sponsors of pediatric drugs need to know. Among the regulatory hurdles: A new emphasis on transparency in labeling and tougher rules for pediatric exclusivity.
White Paper April 01, 2010