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All Tissue/Cell Product Firms Must Register With CBER Under Proposed Rule

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers of human cellular and tissue-based products will be required to register and list their products with the Center for Biologics Evaluation and Research regardless of whether their products fall under the agency's new tissue regulation or continue to be regulated as devices or biologics, FDA says in a May 14 proposed rule.

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Public meeting scheduled for Aug. 2 at the NIH campus in Bethesda, Maryland, is being organized by FDA's devices and biologics centers to provide a public forum for gathering scientific data, information and views from interested persons about human bone allografts in relation to FDA's proposed tissue rules (1"The Gray Sheet" May 25, 1998, p. 13). Entitled "Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair," the meeting is intended to "provide stakeholders with the opportunity to present additional information to the agency," FDA says. The agency "is requesting specific information concerning the characteristics of various bone products as they relate to the agency's proposed definitions for minimal manipulation and homologous use"

Cosmetic And Personal Care Trademark Review 24 November, 2020

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