FDA Works to Advance Real-World Data Collection in Pregnancy and Lactation
RAPS | May 16, 2022
Takeaways from a public workshop hosted by Johns Hopkins Center of Excellence in Regulatory Science and Innovation and the FDA Office of Women’s Health about real-world data to help understand the safety and efficacy of medications used during pregnancy and lactation.
Prescribing Without Data: Doctors Advocate for the Inclusion of Pregnant People in Clinical Research
AAMC | March 22, 2022
Piece describing how researchers at academic medical centers are taking on efforts to expand the research and knowledge base for including pregnant and lactating populations in clinical trials so health care providers are equipped with data that can help them help their patients make treatment decisions.
The Program Meant to Help Pregnant People Safely Find Prescriptions to Take Has Stalled
FORTUNE | February 13, 2022
Article describing how pregnant and lactating people are routinely excluded from clinical trials and the role of PRGLAC to close those gaps. *Subscription required.
Office of Rep. Lois Frankel | January 21, 2022
Press release sharing that Reps. Lois Frankel (D-FL-21), Jaime Herrera Beutler (R-WA-03), and Lucille Roybal-Allard (D-CA-40) and 62 bipartisan members of Congress sent a letter to HHS urging the extension of the charter for PRGLAC or establish a similar advisory committee to continue carrying out PRGLAC’s work
Pregnant People Were Shut of Clinical Trials — With Disastrous Results
POLITICO | November 1, 2021
Article on how the decision to exclude pregnant people from the first wave of COVID-19 clinical trials “created a data gap that inadvertently fueled vaccine hesitancy — in some cases, with deadly consequences.”
Pregnant Women Must Be Included in Medical Research
Scientific American | December 19, 2020
Opinion piece from Kathryn G. Schubert, President and CEO of the Society for Women’s Health Research, on the importance of implementing PRGLAC recommendations through the context of the COVID-19 pandemic.
NIH Task Force on Pregnancy and Lactation Receives Two-Year Renewal
NIH Media Advisory | March 25, 2019
Press release announcing that PRGLAC has been renewed for an additional two years by the Secretary of Health and Human Services.