HUMAN TISSUE PRODUCTS WOULD NOT BE SUBJECT TO PLA APPROVAL PROCESS UNDER BIO/PhRMA JOINT FDA REFORM DRAFT BILL; NON-TISSUE PRODUCTS COULD BE INCLUDED
Proof of efficacy would not be required for human tissue products under a joint FDA reform draft proposal developed by the Biotechnology Industry Organization and the Pharmaceutical Research & Manufacturers of America being circulated the week of July 31.
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