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MoCRA Implementation Would Benefit From ‘Better Planning’ – Government Accountability Office

 
• By Eileen Francis

US FDA has not developed an implementation plan for the Modernization of Cosmetics Regulation Act, nor a strategic workforce plan to support MoCRA rollout, the US Government Accountability Office says in a 6 December report to Congressional requesters.

The US Food and Drug Administration has taken “important steps” to implement the Modernization of Cosmetics Regulation Act, but it has not addressed the organizational changes necessary to implement the law, among other shortcomings, says the US Government Accountability Office.

In a 6 December report to unnamed congressional requesters, GAO summarized conclusions from an audit conducted November 2021 to...

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AESGP Annual Meeting: Harmonizing EU VMS Max Levels Could Cost Sector Over €200m

 
• By David Ridley

Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

Review Suggests Advantage Of Bayer’s Iberogast Advance For Digestive Disorders

 
• By David Ridley

Bayer's Iberogast Advance's combination of six herbal ingredients may produce a synergistic effect that acts on multiple underlying issues contributing to digestive disorders like functional dyspepsia (FD) and irritable bowel syndrome (IBS), a recently published study suggests.

Allergy Ingredient Itch Warning, ACNU Final Rule Scratch Extent Of FDA Authority For Label Changes

 
• By Malcolm Spicer

Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.

More from HBW Insight

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”