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Will ACNU Proposal’s Dual Rx/OTC Component Simultaneously Help And Hinder Switches?

 
• By Malcolm Spicer

Proposal is counter to fundamental of FDA platform for approving drugs as either Rx or OTC, with a formulation of a drug with a certain indication available in one class, not both. CHPA says the proposal also runs counter to encouraging pharma firms to invest in research needed for OTC switches.

• Source: Shutterstock

Allowing simultaneous Rx and OTC sales of the same drug, a part of a US proposed rule for facilitating OTC switches, could help pharma firms “have the best of both worlds” but also could become a disincentive for investing in preparing applications to move ingredients to nonprescription.

In a separate reference in its recent notice on preparing applications for OTC distribution of naloxone, the Food and Drug...

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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

Poland’s Formeds Acquired By Private Equity

 
• By Tom Gallen

Enterprise Investors takes 77% stake in Polish clean-label dietary supplements manufacturer Formeds.

FDA Proposes Requiring Unit-Dose Packaging For Orally Disintegrating OTC Monograph Drugs

 
• By Malcolm Spicer

Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential

TikTok Shop More Popular For Beauty Than Online Sephora, Shein – Survey

 
• By Eileen Francis

Social platforms like TikTok Shop have “completely reshaped product discovery, creating a new shopping paradigm” for beauty and taking share from traditional beauty retailers, according to retail brand experience agency ChangeUp, Inc.