FDA Workshop To Consider Pediatric Research Rules Compliance By OTCs Available Through NDAs

Potential formulations for OTC oral analgesic and antipyretic drugs the US Food and Drug Administration may consider for approval through applications are the reasons for a public workshop the agency has scheduled in November.

Compliance by new drug application sponsors with the Pediatric Research Equity Act frames the discussion for the 15 November workshop, leaving off the agenda longstanding questions the agency, industry stakeholders, consumers and members of Congress have about pediatric