FDA Virtual Public Meeting on Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials

The Food and Drug Administration announceded a virtual public meeting titled “Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.” The meeting will be convened on February 2nd and 3rd by Duke University’s Robert J. Margolis, MD, Center for Health Policy, and supported by a cooperative agreement with FDA.

The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.

The meeting will allow participants to provide input on key topics, including:

  • Regulatory, scientific, and ethical considerations for the enrollment of pregnant women in clinical research, as articulated in existing FDA Guidance;
  • Priority areas of unmet need for clinical data collection and therapeutic development in obstetrics;
  • Characteristics of a standard nonclinical program designed to assess the safety of a product in the antenatal period; and,
  • Clinical trial designs for studies enrolling pregnant women to evaluate the safety and efficacy of therapeutics for chronic or acute medical conditions that require treatment during pregnancy.

Input from this meeting will help provide information on the development of therapies for pregnancy-specific conditions and for general medical conditions that occur in women of childbearing age and require treatment during pregnancy. Additionally, input may also help further inform FDA’s work to finalize the agency’s draft guidance, “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials”.

Registration for the public meeting is now open. The virtual meeting will take place on:

  • February 2, 2021 (12:00 pm – 4:00 pm EST)
  • February 3, 2021 (12:00 pm – 3:00 pm EST)

Click here to learn more: https://www.fda.gov/drugs/news-events-human-drugs/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials-public-meeting?utm_medium=email&utm_source=govdelivery

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