Healthy Skepticism Library item: 9560

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Guideline labeling texts for progestational drug products for human use
Federal Register 1989 Jan 12; 54:1243-1244

Abstract:

The revised Food and Drug Administration guideline texts are presented for the professional and patient warning labeling required for prescription progestational drug products to which holders of approved new drug applications for such products are subject; labeling information should warn against use of the drugs in the first trimester of pregnancy and of the resultant risk of genital abnormalities in the fetuses.