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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 the firm’s TEA for drometrizole trisiloxane are insufficient to determine...

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More from United States

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• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

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More from North America

Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 
• By Lauren Flynn Kelly

Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.