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GUIDANCE DOCUMENT

Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials April 2018

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-1201
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides recommendations about how and when to include pregnant women in drug development clinical trials for drugs and biological products based on the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this subject. Specifically, this guidance supports an informed and balanced approach to gathering data on the use of drugs and biological products during pregnancy through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk. This draft guidance is intended to serve as a focus for continued discussions among various entities such as the Agency, pharmaceutical manufacturers, the academic community, institutional review boards (IRBs), and others who are involved with the conduct of clinical trials in pregnant women.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1201.

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