Biological Products; In Vitro or In Vivo Monoclonal Antibodies
United States. Food and Drug Administration
FEDERAL REGISTER 49(5): 1136, 9 January 1984
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Department of Health and Human Services. Food and Drug Administration. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients Letter and Attachment From Robert P. Murphy, General Counsel, United States General Accounting Office to Sen. James M. Jeffords and Sen. Edward M. Kennedy and Rep. Thomas J. Bliley, Jr. and Rep. John D. Dingell Murphy, Robert P. (United States. General Accounting Office [GAO], 1998-12-21)