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US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

 
• By Malcolm Spicer

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.

• Source: Shutterstock

The US Food and Drug Administration’s rejection of a citizen petition on children’s doses of OTC monograph liquid acetaminophen ties a knot in a loose end related to considering compliance with pediatric research requirements in potential applications for oral analgesic and antipyretic OTCs.

The agency’s Center for Drug Evaluation and Research rejected the petition submitted in April by Parenteral Technologies LLC as it...

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