DONALD S. ROBINSON, M.D.
The clinical investigation of new drugs has come under increasing scrutiny and control, mainly as a result of two factors. One is passage of the 1962 Kefauver Amendment to the Food and Drug Act, an aftermath of the thalidomide catastrophe. The other is a growing national concern about protection of human subjects and ethical controls, which have come about in part from adverse publicity over clinical research involving prisoners, mentally retarded persons, and impaired patients. This concern has led the National Institutes of Health to develop recommended policies (1) for research involving children, prisoners, and the institutionalized mentally infirmed. The
ROBINSON DS. Evaluation of Drugs Used in Pregnancy and Pediatric Age Groups. Ann Intern Med. ;82:841–842. doi: 10.7326/0003-4819-82-6-841
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Published: Ann Intern Med. 1975;82(6):841-842.
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