Second Wind For OTC Monograph User Fee Legislation In House Hearing

House Health Subcommittee's “Modernizing FDA’s Regulation of Over-the-Counter Drugs” hearing Sept. 13 will "examine draft legislation to establish" a user fee program to support FDA's work on evaluating proposals for additions or changes to its nonprescription drug monographs.

Chances this year for legislation on reforming FDA's OTC drug monograph program and creating a user fee to support it could be revived as a House subcommittee expects to have a draft bill ready for a hearing on Sept. 13.

The Energy and Commerce Committee's Health Subcommittee's “Modernizing FDA’s Regulation of Over-the-Counter Drugs” hearing will "examine draft legislation to establish"...

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

More from Ingredients & Safety

Gardenia Blue, OrangeOvation, StellarYellow Latest Natural Pivots In US Food Color Market

 

FDA’s fourth approval in past two months for color derived from natural sources to use in foods is Gardenia Blue Interest Group’s color additive petition for gardenia blue. Lycored launches StellarYellow and C Clear as alternatives for synthetic dyes yellow Nos. 5 and 6 and OrangeOvation C Clear for

House OMUFA Reauthorization Bill Takes On Clarifying Standards For Tests To Meet GRASE

 

Health Subcommittee will discuss reauthorizing OMUFA during a hearing on how to “maintain and improve” the public health workforce and rural health as well as access to OTC medicines.

Pharma Deutschland Seeks To Enter Urban Wastewater Legal Dispute

 
• By 

The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.

UK FSA Issues New Guidelines For CBD And THC Max Levels

 
• By 

Based on advice from its advisory committees, the UK's Food Standards Agency is encouraging businesses to meet an acceptable daily intake of 10mg CBD per day and a safe upper limit of 0.07mg THC per day.

More from HBW Insight

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By 

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.

International Self-Care Day: ‘Cyberchondria’ In The UK, Best Practices In The EU

 
• By 

On International Self-Care Day 2025 (July 24) PAGB releases its latest Self-Care Census which finds self-care confidence declining in the UK and AESGP launches a digital platform showcasing national-level self-care initiatives.