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1 Endocrinologic
and Metabolic Drugs Advisory Committee
The development of male contraceptive drugs
is of great scientific importance for andrologists as well as being of vital world interest. The
American Society of Andrology, therefore, welcomed the opportunity to work closely with the
Division of Metabolism and Endocrine Drug
Products of the Food and Drug Administration
(FDA) in formulating appropriate guidelines for
clinical testing of male contraceptive drugs.
During the past year, a committee of the Society
consisting of Drs. Nancy Alexander, Andrzej
Bartke, Glenn R. Cunningham, Richard M. Harrison, Thomas J. Lobi, Howard R. Nankin, D. J.
Patanelli, C. Alvin Paulsen, Eugenia Rosemberg, Richard J. Sherins, Emil Steinberger,
Ronald S. Swerdloff, and myself has reviewed
and commented on proposed guidelines as
they have been drafted by the FDA. Although some members of the committee
have individual reservations on some items,
there is general agreement that the guidelines
as presented here are a viable and useful approach to a complex area of clinical investigation. However, the final responsibility for the
guidelines properly remains with the Food and
Drug Administration. Further experience will
indicate whether additional modifications will
be necessary. We are pleased that the Society
has been privileged to play a role in this process.
Accepted on March 20, 1981
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