Warning Letter Heralds Stepped-Up Enforcement Against Cell-Based Regenerative Medicine Product Manufacturers

Dennis Tosh
January 10, 2018 at 12:39 PM EST
Less than two months after rolling out “a comprehensive framework for the development and oversight of regenerative medicine products” that included periods of enforcement discretion for some products subject to premarket review, the FDA has vowed increased enforcement action targeting regenerative medicine products that pose significant safety concerns. On Jan. 3 the FDA iss... Read More

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