Assessment of Preclinical Reproductive Toxicity Data; Public Meeting

Streszczenie

The Food and Drug Administration (FDA) is announcing a public meeting to discuss an approach for the integrative assessment of preclinical reproductive toxicity findings and other information for pharmaceuticals. The purpose of the meeting is to provide information on the agency's approach, using several pharmaceutical data sets, and to invite members of the public to provide comments on the utility of the approach. The agency intends to consider feedback from the meeting in the development of guidance for integrative assessments of pharmaceutical reproductive risk.