Karlye Sopczak on Muck Rack

Karlye Sopczak

As seen in: JD Supra, Mondaq
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Articles

Federal Court Hands Major Win To Tissue Product Manufacturers – FDA’s HCT/P Classification Decision For Umbilical Cord–Derived Product CORDGRAFT Rejected

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By Christopher T. Grohman, Karlye Sopczak
| Mondaq
Benesch Friedlander Coplan & Aronoff LLP are most popular: within Litigation and Mediation & Arbitration topic(s) A federal court rejected the FDA’s classification of an umbilical cord–derived product, finding the agency misapplied its own “minimal manipulation” standard and must reconsider the product’s regulatory status—potentially making it easier for similar tissue products to qualify for the less burdensome Section 361 pathway.
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Federal Court Hands Major Win to Tissue Product Manufacturers - FDA’s HCT/P Classification Decision for Umbilical Cord–Derived Product CORDGRAFT Rejected

|
By Christopher T. Grohman, Karlye Sopczak
| JD Supra
Key Takeaways A federal court rejected the FDA’s classification of an umbilical cord–derived product, finding the agency misapplied its own “minimal manipulation” standard and must reconsider the product’s regulatory status—potentially making it easier for similar tissue products to qualify for the less burdensome Section 361 pathway. This is a significant check on FDA authority and could shift the regulatory landscape for tissue and regenerative medicine products.
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