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

US Oral Contraceptive OTC Switch Sponsor Says ‘Challenging Target’ Met For Adolescents In Study

 
• By Malcolm Spicer

HRA executives and other representatives for firm and FDA officials will make presentations about HRA’s sNDA to agency’s Nonprescription Drug and Obstetrics, Reproductive and Urologic Drugs advisory committees during a joint meeting on 9-10 May.

• Source: Shutterstock

HRA Pharma spares no detail on the benefits of allowing adolescent access in the information it provided to an advisory panel recommending whether the Food and Drug Administration should approve its proposal for the first Rx-to-OTC switch of a daily oral contraceptive in the US.

The Perrigo Company PLC subsidiary also counters FDA concerns about the numbers of adolescent and of low healthy literacy...

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

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.

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.

Sunscreen Regulation Reforms Still Could Hitch Ride On Senate OMUFA Reauthorization Bill

As stakeholders and lawmakers pin their hopes on OMUFA reauthorization as a vehicle for enacting sunscreen regulatory changes, Senate version of the bill could be the ticket after a sunscreen-specific amendment withdrawn in the House.