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Unapproved Cell/Tissue Product Enforcement Discretion Ends; How Hard Will US FDA Crack Down?

 
• By Derrick Gingery

Entities that already have received letters from the agency raising concerns about marketing unapproved products may not necessarily be the first to face enforcement actions, CBER official says.

Person cracking a nut
Should sponsors expect a flurry of enforcement activity now that the FDA's discretion policy has ended? • Source: Alamy

The list of sponsors suspected of marketing unapproved human cell, tissue, and cellular and tissue-based products (HCT/P) that previously received notices from the US Food and Drug Administration may not represent the agency’s priority now that enforcement discretion has ended.

The most recent extension of the agency’s discretion policy expires 31 May and was not renewed

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