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Industry Seeks FDA Flexibility Around MoCRA Registration And Listing; Attorneys Discuss

 
• By Eileen Francis

Companies have concerns about how the FDA will respond if struggles to obtain data, or hiccups in the cosmetic product facility registration or listing process, lead to errors or deadline misses under the Modernization of Cosmetics Regulations Act. Attorneys from Duane Morris and Covington & Burling provide views on FDA’s related draft guidance, key challenges facing industry, and how the agency may proceed.

• Source: Shutterstock (Shutterstock)

Stakeholders commenting on the US Food and Drug Administration’s draft guidance on registration and listing requirements under the Modernization of Cosmetics Regulations Act (MoCRA) will urge the agency to use enforcement discretion as concerns grow over the approaching year-end deadline.

Two attorneys who spoke with HBW Insight on 10 August, three days after the guidance was released, said cosmetic...

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