Biologics Evaluation Section

A section of the Investigational Drug Branch of the FDA, which develops drug-development plans, including Phase-I, Phase-II and Phase-III trials, for biological response modifiers (BRMs) and co-ordinates with intramural and extramural investigators and the pharmaceutical industry in the design and the conduct of these trials; monitors clinical trials of BRMs for safety, efficacy and clinical pharmacology; investigates and prepares reports concerning adverse effects for all investigational new drugs; and provides annual reports to the FDA on biological agents.

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