A Twenty Year Summary of FDA Animal Safety Testing of Contraceptive Steroids
I think it is useful to present a little history. In 1962, the Kefauver-Harris Amendments were enacted and a new approach to the drug approval process was implemented. That approach included a formalized investigational new drug application. As part of that program there were suggestions made that certain preclinical tests be performed before the Phase I studies of the IND could be initiated.
KeywordsAssure Progesterone Progestin Provera Norethindrone
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