FDA allergenic product guidelines
Revised draft guideline is now available through the agency's Biologics Information Staff, Building 29, Room B-16, 8800 Rockville Pike, Bethesda, Maryland, 20892. The telephone number is 301/496-9508. Comments on the draft proposal to assist manufacturers in the design of clinical studies for allergenic products are due April 3 at FDA's Dockets Management Branch ....
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