U.S. flag An official website of the United States government
  1. Home
  2. Science & Research
  3. Science and Research Special Topics
  4. Women's Health Research
  5. Pregnancy Research Initiatives
  1. Women's Health Research

Pregnancy Research Initiatives

The FDA Office of Women’s Health (OWH) leads pregnancy and lactation research initiatives and works closely with FDA Centers to support policy, research, education, outreach and other efforts to help increase available safety information on FDA-regulated products used during pregnancy and lactation. OWH also works to address emerging issues related to pregnancy, such as the outbreaks of Zika virus, Ebola virus, and COVID-19

This webpage highlights the multi-pronged approach used by OWH to advance knowledge of the safety and efficacy of FDA regulated medical products used during pregnancy and lactation.

OWH-Funded Research

The FDA Office of Women’s Health awards research grants to support FDA regulatory decision-making through our intra and extramural research programs. OWH has funded research projects across FDA Centers and in collaboration with academic partners through the Centers of Excellence in Regulatory Science and Innovation and FDA’s Broad Agency Announcements.

OWH-Funded Research: Pregnancy and Lactation

Pregnancy Exposure Registries

Pregnancy exposure registries are important tools used to gather data on the effects of medical product exposures during pregnancy. The FDA Office of Women’s Health created a web portal listing active pregnancy exposure registries and collaborates with public and private partners to conduct outreach to connect pregnant individuals and health professionals with medical product registries that collect information on prescription medicines or vaccines taken during pregnancy.

List of Pregnancy Exposure Registries

Scientific Meetings and Workshops

OWH hosts workshops to disseminate the findings of funded pregnancy research and collaborates with the FDA Centers on public meetings to foster scientific dialogue on methods to collect data on medical product exposures during pregnancy.

Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)

The 21 Century Cures Act established the PRGLAC Task Force to advise the Secretary of HHS regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. The FDA Office of Women’s Health leads the FDA committee and serves as a member of the PRGLAC Task force.

Learn more about the Task Force on Research Specific to Pregnant Women and Lactating Women

FDA Policy and Guidance

Pregnancy and Lactation Labeling Final Rule

On December 3, 2014, the FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule).

The final rule applies to biological products subject to the Physician Labeling Rule. This rule also applies to products regulated by the Center for Biologics Evaluation and Research, including, but not limited to: vaccines, allergenics and cellular and gene therapies.

Pregnancy and Lactation Labeling Final Rule

Questions and Answers on the Pregnancy and Lactation Labeling Rule

FDA Guidance Related to Pregnancy Research

(2020) FDA Final guidance Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry - Guidance recommends approaches that sponsors of clinical trials can take to increase enrollment of underrepresented populations in their trials. It further recommends including pharmacokinetic sampling to establish dosing in women who become pregnant during a trial when it is possible for continued participation in the trial and the benefits are expected to outweigh the risks.  
(2020) Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry - Guidance on how to develop the content and format of the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products.
(2019) FDA Draft Guidance: Clinical Lactation Studies: Considerations for Study Design - Guidance outlines FDA’s current recommendations regarding pre- or post-marketing lactation studies by drug sponsors.
(2019) FDA Draft Guidance: Postapproval Pregnancy Safety Studies Guidance for Industry - Guidance for sponsors and investigators on how to design pregnancy safety studies to assess the outcomes of pregnancies in women exposed to drugs and biological products regulated by FDA.
(2018) FDA Draft Guidance: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials - Guidance provides FDA’s current recommendations about how and when to include pregnant women in clinical trials supporting the development of drugs and biological products.
(2018) Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products - Guidance provides updated recommendations for screening donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) for evidence of, and risk factors for, infection with Zika virus (ZIKV).
(2016) Draft Guidance on Premarket Tobacco Applications for Electronic Nicotine Delivery Systems (CTP) - Draft guidance discusses the scientific information that can be included in a PMTA on the likelihood of product use by pregnant women and other vulnerable populations. New tobacco products must meet the protection of public health standard before receiving a marketing authorization.
(2016) Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD).
(2015) Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format - Guidance on how to develop sections of prescription drug and biological products labeling for women who are able to become pregnant, pregnant, or lactating.
(2011) Reproductive and Developmental Toxicities —Integrating Study Results to Assess Concerns - Guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a nonclinical finding of toxicity has been identified, but definitive human data are unavailable.
(2006) Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications - Guidance outlines general and specific recommendations in the assessment and conduct of developmental toxicity studies for investigational vaccines for infectious disease indications.
(2005) Evaluating the Risks of Drug Exposure in Human Pregnancies - Guidance on how to evaluate data concerning fetal exposure to medical products during pregnancy to assist in the development of product labeling regarding risks.
(2005) Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies - Guidance provides recommendations on how to evaluate the risks of drug exposure in human pregnancies.
(2004) Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling Guidance on how to design and conduct studies to consider how pregnancy influences the pharmacokinetics or pharmacodynamics of drugs or biological products.

Consumer Education and Outreach

Health Resources for You and Your Baby Initiative

This initiative disseminates plain language fact sheets, videos, and social media resources on medication use during pregnancy. It also utilizes the FDA Pregnancy webpage to raise awareness about medication and other product safety information related to pregnancy and lactation.


Resources For You

Back to Top