Biologics Regulation and ResearchThe People and Work of Buildings 29 & 29A

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In February 1973 FDA finalized plans to conduct a systematic efficacy review of all licensed biological products, modeled on its review of over-the-counter drug products that had been launched the previous year. Commissioner Charles Edwards appointed six advisory panels of experts that would review the evidence and assign each biological product to one of the following categories: safe and effective; unsafe and/or ineffective;   requiring further study but to remain available in the interim;   and lacking sufficient data to be determined safe and effective and recommended for market removal. Much as the case with new drugs, the proof of effectiveness would be expected to derive from adequate and well-controlled investigations. And much like the case with drugs, the review lasted decades. Along the way, though, some licenses have been revoked, such as in 1977 when FDA announced its intention to revoke the licenses of eight skin tests for tuberculosis, diphtheria, and other diseases and conditions.

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