Clock Ticks On Adding OTC Monograph Reform To FDA User Fees Bill

With Congress leaving Washington for Independence Day week and much of August, few days remain to consider adding to each chamber's reauthorization legislation language from Sens. Isakson and Casey's discussion draft for US OTC monograph reform and a user fee program to support FDA's work.

Business time concept as a group of running businessmen and businesswomen using a giant clock to cross over a cliff as a bridge as a metaphor for schedule and appointment speed as a 3D illustration.

Time is running short and competing issues are stacking high for adding OTC monograph reform and user fees to legislation reauthorizing FDA's existing user fee programs for another five years.

With Congress leaving Washington during the week of Independence Day and for much of August, few days remain for House and Senate committees to consider adding to language from Sens....

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

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.