Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop; Request for Comments

The Food and Drug Administration (FDA) is announcing a public workshop entitled "Optimizing the Use of Postapproval Pregnancy Safety Studies" convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis. This workshop will include discussions of designs of postapproval pregnancy safety studies for drug and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and experiences with implementing these studies. The workshop also will include discussion of considerations for further development of a framework that describes how data from different types of postapproval pregnancy safety studies might optimally be used when it has been determined that this data should be collected.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.