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OMOR Or Not To OMOR: Proposals Will Push US OTC Monograph Fees Past Requested Level

 
• By Malcolm Spicer

Payments FDA receives could expand from facility fees between $13,548 and $20,322 collected from around 1,700 firms for the current fiscal year to include payments of $500,000 or $100,000 from firms for proposed monograph changes.

OTC monograph drug program user fees the US Food and Drug Administration requested for fiscal year 2022 are up slightly from the agency’s current budget, but the total amount it collects in the 12 months starting October could be much larger.

That’s because the payments the FDA receives under the program could expand from the facility fees from around 1,700 firms it received for the current fiscal year to include payments...

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FTC Consumer Privacy Policy Driven By ‘Straw Man’ Arguments – Commissioner Holyoak

 
• By Eileen Francis

The US FTC’s contention that ‘notice and choice’ has failed as the cornerstone of consumer privacy regulation and must be abandoned in favor of data minimization and other more stringent measures does not adequately account for the complexity of business practices and consumer behavior, FTC commissioner Melissa Holyoak asserted at the NAD’s 2024 Annual Conference.

FTC’s New Commissioner ‘Dismayed’ By Agency Overreach

 
• By Eileen Francis

FTC Commissioner Melissa Holyoak says the agency has acted outside the bounds afforded by Congress, citing several areas within consumer protection, including a recent update to the final rule for the Health Breach Notification Rule and the commission’s use of notices of penalty offense to serve as the basis for Section 5 settlements. 

Beauty Brands Not On TikTok Shop ‘Really Missing Out’ – KO-Pack

 
• By Eileen Francis

At one year, TikTok Shop conjures the early days of Amazon, representing the ‘Wild West’ of beauty ecommerce, said co-founders of private label and contract manufacturing company KO-Pack at the IBA Cosmetics Convergence Fall 2024 Virtual Symposium, “The Promise and Pitfalls of TikTok Shop.”

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

More from HBW Insight

EU’s Small, Medium Beauty Industry Pushing For Clarity In Revised CPR

French SME association COSMED will push the European Commission for a “clear checklist” and criteria on how substances in the Cosmetic Products Regulation are assessed by Member States, as well as more clarity on the exemption process and timelines.

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

 
• By Derrick Gingery

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.

Dermapharm Seeks To Put Stop To Spanish Slide

 
• By Tom Gallen

Dermapharm shakes up management of Arkopharma subsidiary in Spain with turnaround plan not showing results.