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

Description

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 This draft guidance is intended to serve as a focus for continued discussions among various entities such as the Agency, pharmaceutical manufacturers, the academic community,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.

Scope & Applicability

Regulatory Context

• 21CFR56.107§ 56.107 IRB membership.

  (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members,Read full regulation →

• 21CFR56.111§ 56.111 Criteria for IRB approval of research.

  (a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:Read full regulation →

• 21CFR50.3§ 50.3 Definitions.

  As used in this part:Read full regulation →

• 21CFR312.50§ 312.50 General responsibilities of sponsors.

  Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan Read full regulation →

• 21CFR312.56§ 312.56 Review of ongoing investigations.

  (a) The sponsor shall monitor the progress of all clinical investigations being conducted under its IND.Read full regulation →

• Bioresearch Monitoring Program

  Amy Lightner, MD

  2025-06-03

• Institutional Review Board (IRB)

  Armstrong County Memorial Hospital

  2024-11-05

• Institutional Review Board (IRB)

  Louisiana State University Health Science Center IRB

  2024-10-08

• Bioresearch Monitoring Program/IRB

  Massachusetts Institute of Technology MIT

  2024-07-16

• Clinical Investigator (Sponsor)

  Angela D. Ritter, M.D.

  2024-06-18

• Institutional Review Board (IRB)

  New York State Psychiatric Institute IRB

  2024-03-26

• Clinical Investigator

  Jeffrey W. Taub, M.D./Children's Hospital of Michigan

  2024-01-09

• Clinical Investigator

  Luis Javier Pena-Hernandez, M.D., FCCP

  2023-09-29

• Bioresearch Monitoring Program/Institutional Review Board (IRB)

  Larkin Community Hospital Institutional Review Board

  2023-01-24

• Clinical Investigator (CI)

  Sabine S. Hazan, M.D.

  2022-03-15

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• Chapter 48 7348.809A Radioactive Drug Research Committee (Status: Final)
• CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
• Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Status: Final)