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
- Pregnancy Exposure Registries
- Scientific Meetings and Workshops
- Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)
- FDA Policy and Guidance
- Consumer Education and Outreach
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.
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.
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.
- 2021 Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.
- 2020 CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses - Included discussion of current understanding of the risks associated with cannabis and CBD use during pregnancy and lactation and highlighted critical knowledge gaps.
- 2018 Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender - Included a discussion on pregnancy and the postpartum period.
- 2019 The Safety of Asthma Medications During Pregnancy: Research Priorities and Methodology.
- 2014 Public Meeting: Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products during Pregnancy in the Post-Approval Setting.
- 2011 Pregnancy and Prescription Medication Use Symposium - Increased awareness regarding the use of prescription medications used during pregnancy and the need for ongoing studies to improve pregnancy labeling.
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.
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.
FDA Guidance Related to Pregnancy Research
(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.
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.