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OTC Monograph Reform Could ‘Unlock’ Innovations In Three Years

 
• By Eileen Francis

Following enactment of US OTC monograph reform, drug companies will unleash formulation innovations after keeping a lid on monograph R&D, CHPA anticipates. "A lot of companies have ideas like this they’ve kind of put in a drawer, that we think this is gonna unlock,” says David Spangler, an executive with the OTC trade group.

Significant nonprescription drug innovations likely would start to reach the market within a few years of an overhaul of US FDA's OTC monograph program as manufacturers make proposals for formulation and other changes they've been sitting on due to the current system's problems, the Consumer Healthcare Products Association predicts

"We know a lot of companies have ideas like this they’ve kind of put in a drawer, that we think...

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More from Regulation

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.

Animal Studies Would Not Provide ‘Meaningful Insights’ Into UV Filter Safety - Study

 
• By Lauren Nardella

A new study on the safety of sunscreen filters relies on an alternative assessment methodology and concludes that six sunscreen UV filters are unlikely to be carcinogenic.

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.

US FDA Expert Panel Paints Bleak Picture For Future Of Talc In Cosmetics

 
• By Eileen Francis

The US FDA’s 20 May expert panel on talc discussed science behind the potential carcinogenicity of the cosmetic, food and drug ingredient, the importance of ‘good science’ in evaluating the substance and the need to find alternatives in each industry.

More from Policy & Regulation

IBA Interactive Policy Map Is Call To Action As Cosmetics Industry Braces For Myriad Of State Bills

 
• By Eileen Francis

The Independent Beauty Association has launched an interactive Policy Map tracking state and federal bills and filtering by state or topic, pinpointing bills of great priority.

Animal Studies Would Not Provide ‘Meaningful Insights’ Into UV Filter Safety - Study

 
• By Lauren Nardella

A new study on the safety of sunscreen filters relies on an alternative assessment methodology and concludes that six sunscreen UV filters are unlikely to be carcinogenic.

Cosmetics Industry: Push Congress To Apply Pressure On MoCRA – Attorney

 
• By Eileen Francis

The US cosmetics industry, particularly small- and medium-sized businesses, should reach out to their representatives in Congress to encourage pressure on the US Food and Drug Administration to implement cosmetics reform, despite agency staff cuts.