Jamie Ravitz and Naomi Halpern Co-Author Article on HCT/Ps for Today’s Wound Clinic
Food, Drug, Medical Device, and Agriculture practice group leader Jamie Ravitz and counsel Naomi Halpern co-authored the article, “FDA Regulation of HCT/Ps: What Wound Care Practitioners Need to Know,” featured in the December 2016 issue of Today’s Wound Clinic. The article focuses on what providers in the wound clinic industry need to know regarding the FDA’s regulation of human cells, tissues, and cellular- and tissue-based products (HCT/Ps). Over the last 5-8 years, there has been growing concern among some regulators, clinicians, biological product distributors, and patient communities that some HCT/Ps are being marketed under Section 361 of the Public Health Service Act (PHSA) when they do not actually meet the requirements for marketing under this simplified framework. FDA’s draft guidance, when finalized, is intended to bring clarity to the industry for marketing a HCT/P under Section 361.
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