1. HBW Insight
  3. >>Policy & Regulation

US FDA OTC Monograph Meetings Guidance Should Be Familiar To Firms Using NDA Pathway

 
• By Malcolm Spicer

Recent draft guidance on scheduling FDA meetings to discuss potential OTC monograph order requests marks step in program overhaul authorized in 2020 legislation, but isn’t a signal for manufacturers, other industry stakeholders to expect meetings soon.

• Source: Alamy

The Food and Drug Administration’s overhauled OTC monograph program resembles the agency’s process for prescription drug applications not only for adding ingredients and indications but also for scheduling meetings application sponsors will have with agency officials.

Still, while a recent draft guidance on scheduling meetings with agency officials to discuss potential OTC monograph order requests...

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

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
• By Derrick Gingery

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

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.

Urban Wastewater Directive: AESGP Requests Intervention In EFPIA’s Legal Action

 
• By David Ridley

AESGP has formally submitted a request to the General Court of the European Union to intervene in the European Federation of Pharmaceutical Industries and Association’s legal action against the revised EU Urban Wastewater Directive.

More from Policy & Regulation