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In
the wake of the new law, the Division of New Drugs was restructured into five branches in
1962. The Investigational Drug Branch, directed by Kelsey, evaluated proposed clinical
trials for compliance with investigational drug regulations. Earl Meyers, who began his
career with FDA in 1939, was the director of the Controls Evaluation Branch, which
reviewed the manufacturing controls proposed by drugs makers. The Medical Evaluation
Branch assessed safety and efficacy data in NDAs. The New Drug Status Branch, under John
Palmer, consulted with manufacturers about their NDAs and proposed dosing schedules for
new products. The last branch, New Drug Surveillance, evaluated adverse reaction reports.
Ralph Smith remained Division director, though he also served
as acting Medical Director from the time Kessenich departed (1962) until March 1964, when
Joseph Sadusk was appointed to that position. Sadusk chaired the
Department of Preventive Medicine and Community Health at George Washington University
before he joined FDA. Under Sadusk, the Bureau of Medicine consisted of four Divisions:
Medical Review, directed by Howard Weinstein, New Drugs, directed by Smith, Research and Reference, under George Saiger, and Veterinary
Medical, which was headed by Charles Durbin. |
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