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L’Oreal Falls Short On Safety, Efficacy, Adverse Event Data

 
• By Lauren Nardella

FDA says it needs additional data from L’Oreal on safety, efficacy and adverse events to determine GRASE for drometrizole trisiloxane.

[L'Oreal USA Inc.] needs to furnish additional safety and efficacy data and adverse event information to support sunscreen ingredient drometrizole trisiloxane as GRASE, FDA says in its response to the firm’s time-and-extent application to add the ingredient to the OTC sunscreen monograph.

An Aug. 29 letter to L’Oreal says FDA’s Center for Drug Evaluation and Research determined that data in...

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More from United States

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

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PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

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Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
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More from North America

Anti-Vaccine Activists Among New US CDC Vaccine Advisors

 
• By Sarah Karlin-Smith

HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.

US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.