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FDA, PCPC To Meet On Sunscreen Work Plan; Industry’s ‘Extended’ Study Timelines A Possible Topic

 
• By Lauren Nardella

The US FDA’s deferral of final GRASE rulemaking on UV filters identified in its February proposed rule as lacking data hinges on its acceptance of industry’s work plan. In October, the agency expressed concerns about the plan submitted by the Personal Care Products Council, but granted the group’s request for a meeting – slated for 13 November – to discuss the issues further.

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The US Food and Drug Administration and Personal Care Products Council will meet 13 November, as requested by the latter, to discuss the details of its work plan to support the continued generally recognized as safe and effective (GRASE) status of sunscreen active ingredients.

Topics of discussion could include concerns the agency expressed about industry’s work plan in a

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Some Laid Off Employees Called Back At US FDA

 
• By Sarah Karlin-Smith

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Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

More from North America

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

 
• By Derrick Gingery

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

 
• By Malcolm Spicer

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.