1. HBW Insight
  2. >>Health
  3. >>Policy & Regulation
  4. >>Regulation

US OTC Monograph FY2022 Facility Fees Deadline In June At Amount TBD

 
• By Malcolm Spicer

Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.

• Source: Alamy

The deadline for fiscal year 2021 US OTC monograph program facility fees has passed and the FY2022 fees are due in seven months at amounts not yet set.

What is set, though, is that marketers of OTC drugs available under a Food and Drug Administration monograph which haven’t...

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
Start Free Trial

Already a subscriber?

More from Regulation

More from Policy & Regulation

NDA User Fees Increasing 8.6% As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

Self-Testing Kits Need To Be Regulated Like OTCs, UK Researchers Argue

 
• By David Ridley

Concerns raised by two recent studies prompt UK researchers to argue for greater regulation with regards to direct-to-consumer test kits.

Senate HELP Committee Adds Sunscreen Regulation Overhaul To OMUFA Reauthorization

 
• By Lauren Nardella

OMUFA reauthorization bill including amendment with sunscreen regulation provisions passed by Senate committee, which also approved other provisions not included in House OMUFA bill.