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  1. Clinical Lactation Studies

Clinical Lactation Studies Information for Health Professionals

From the FDA Office of Women's Health

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Health care provider assisting woman with breastfeeding her infant

Find a Clinical Lactation Study Download Clinical Lactation Study Factsheet PDF (4.24MB)

Help your patients enroll in clinical lactation studies

Help your patients voluntarily enroll in a clinical lactation study. The information collected supplements the safety information for medical products (such as prescription medicines and vaccines) used or received while breastfeeding (lactating) and may be used to update the medical product’s labeling. The information collected will be retained in a secure manner. If a participant’s information is shared with researchers and FDA, the identity of the participant will remain private.

  1. Check the list of clinical lactation studies. The listings webpage will include the website and/or phone number for you to contact each study. 
  2. Encourage your patients to voluntarily enroll. The goal of clinical lactation studies is to assess the amount of medicine transferred into breast milk and, in turn, to help evaluate the safety of a medical product in the breastfed infant. Clinical lactation studies may include milk-only studies (used to detect the presence and amount of medicine in breast milk), milk and plasma studies (breast milk and plasma are collected from the lactating woman to provide pharmacokinetic data on the medical product), and mother-infant pair studies (breast milk and plasma are collected from the lactating woman and plasma is also collected from the breastfed infant to determine the absorption of medical products in infants through breast milk). Some of these studies enroll healthy women who are not taking the medical product.
  3. Get medication guides and other resources about safe medicine use to share with your patients. FDA’s Office of Women’s Health (OWH) also offers free publications and information about medicines. 

FDA Office of Women’s Health's (OWH) clinical lactation studies listings webpage is designed to connect breastfeeding women with ongoing clinical lactation studies. The webpage includes a list of studies with the contact information to sign up to volunteer. 

If you are a study sponsor and would like your clinical lactation study added to this list, please email FDA at Registries@fda.hhs.gov. 

New Knowledge and News on Women's Health (KNOWH) blog post: Understanding Clinical Lactation Studies: What They Are and Why They Matter

FDA-funded research on breastfeeding

Although FDA does not conduct any clinical lactation studies, FDA does conduct and fund research to learn more about the safety of medical products used while breastfeeding to expand our knowledge about medicine and vaccine use during breastfeeding. Read about OWH-supported research on pregnancy, lactation, and reproductive health. 

FDA issued draft guidance on the inclusion of pregnant and breastfeeding women in clinical trials 

The draft guidance developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The guideline also provides recommendations for the inclusion and/or retention of pregnant and/or breastfeeding women in clinical trials. FDA published the draft guidance to collect public comments through September 19, 2025. Learn more: E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.

Breastfeeding and medical product labeling

The format and content of prescription medicine and vaccine labeling for information about use while breastfeeding changed in 2015. The “Nursing Mothers” subsection has been renamed “Lactation.” The revised lactation subsection includes more information on whether the medical product gets into breast milk, and – based on how much of it is present – how it can possibly affect the infant. Learn more about the Pregnancy and Lactation Labeling Rule. 

Other medical product information

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