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After US FDA Advisors Unanimously Back First OTC Naloxone Proposal, Meeting On Second Not Needed

 
• By Malcolm Spicer

“Meeting is no longer needed,” agency states in announcement. The same committees’ unanimous recommendation during a meeting in February on Emergent’s sNDA for OTC sales of 4-mg naloxone nasal spray made a repeat for HRT’s NDA for 3-mg spray unnecessary.

• Source: Shutterstock

Harm Reduction Therapeutics Inc. doesn’t have to make an advisory committee presentation for its proposal for an OTC naloxone nasal spray, but still must wait for a US Food and Drug Administration decision it’s confident will be for approval.

The FDA on 1 March announced it cancelled the meeting of its Nonprescription Drug and Anesthetic and Analgesic Drug Products advisory committees to consider HRT’s new drug application for a...

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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.

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Haleon Study: Boosting Health Literacy Could Save Major Economies Over $300bn Per Year

 
• By David Ridley

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.

J&J Plots Next Steps Following Third Failure To Resolve Talc Cases Through Bankruptcy

 
• By Lauren Nardella

After a Texas judge denied a bankruptcy plan, Johnson & Johnson attorneys plan to focus on debunking what they see as dubious scientific claims in civil court.

US FDA Supplement Office Chief Eyes ‘Movement’ This Year On NDI Notifications Final Guidance

 
• By Malcolm Spicer

“We've made some progress and really hope to see some movement as we move forward this year,” says FDA Office of Dietary Supplement Programs director Cara Welch.