Two-Tier OTC Monograph Approach Could Come With User Fee Revamp

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.

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

The approach is proposed in a discussion draft of legislation to create a user fee program for OTC...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Legislation

More from Pink Sheet

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.