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Pregnancy Research Initiatives

Pregnancy Research Initiatives: Enhancing Health for Mother and Child

Many pregnant women need to take medicines. For some it may be to manage a chronic health condition like asthma, epilepsy or hypertension. For others it may be to treat a new condition, which may start to get worse because of pregnancy. While most FDA approved medical products have not been studied for use in pregnancy—stopping or not taking these products may carry serious risks.

FDA is actively working to advance knowledge of the safety and efficacy of medical products used by pregnant women. The FDA Office of Women’s Health (OWH) leads pregnancy research initiatives and works closely with FDA’s Centers to support policy, research and other initiatives to help increase available safety information on FDA-regulated products during pregnancy. OWH also remains at the forefront of FDA efforts to address emerging issues related to pregnancy, like the Zika virus outbreak. This webpage highlights the multi-prong approach used by the FDA Office of Women’s Health to enhance health for mothers and their children.

OWH-Funded Research

The FDA Office of Women’s Health awards research grants to support FDA regulatory decision-making and advance the science of women’s health. OWH has funded research projects and collaborated with other FDA centers to address health issues affecting pregnant women.

OWH-Funded Research: Pregnancy (Prevention/Exposure)

Pregnancy Exposure Registries Initiative

Pregnancy exposure registries are important tools used to gather data on the effects of medical product exposures on the health of a pregnant woman and her fetus. The FDA Office of Women’s Health created a web portal and collaborates with public and private partners to conduct outreach to connect pregnant women and health professionals with over 35 medical product and disease based registries that collect information on drug exposures during pregnancy.


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

The 21 Century Cures Act established the PRGLAC Task Force, led by the National Institutes of Health (NIH), 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.

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

Learn more about FDA’s role in the 21st Century Cures Act.

FDA Policy and Guidance

OWH works to ensure that the science of women’s health and perspectives on the analysis of sex-based differences are integrated into FDA policies and guidance supporting regulatory review of medical products.

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.

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

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.
Establishing Pregnancy Exposure Registries Guidance on how to design and conduct a pregnancy registry to track the results of pregnancies exposed to a certain medical product.
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.
Clinical Lactation Studies – Study Design, Data Analysis, and Recommendations for Labeling Guidance on how to conduct lactation studies and how to analyze the effect of drugs or biologic productions on lactation.
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.
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.
Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components Guidance outlines recommendations to reduce the risk of transmission of Zika Virus by Whole Blood and blood components. 
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).
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.
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.
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.

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

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