1. HBW Insight
  2. >>Wellness
  3. >>Policy & Regulation
  4. >>Legislation

OTC Monograph Reform Proposal Offers Two-Tier Approach

 
• By Malcolm Spicer

One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.

FDA approved background, 3D rendering, blue street sign

Industry could have two tracks for proposing changes to OTC products marketed under the US monograph system: one for adding new medical conditions treated by the ingredients, which would be eligible for exclusivity when clinical trials are required, and another for most other types of changes.

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 Legislation

More from Policy & Regulation