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

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

Pharma Deutschland Seeks To Enter Urban Wastewater Legal Dispute

The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.

Cloudy Tariff Conditions Expected To Linger In US

 

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

FDA Takes World Tour In Recent OTC Warnings

 

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By 

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

More from Policy & Regulation