- January 23 - 24, 2024
- - ET
- - ET
FDA’s Center for Drug Evaluation and Research and the Duke-Margolis Center for Health Policy will host a jointly sponsored virtual public workshop on Advancing Drug Development for the Prevention of Spontaneous Preterm Birth. In the United States, premature birth is the leading cause of infant mortality, with 1 in 10 babies born prematurely. Despite the significant impact and medical need, there are currently no FDA approved treatments for the prevention of preterm births that occur spontaneously.
The workshop will bring together a multidisciplinary group of experts and individuals with lived experience to generate ideas and discussion around the challenges in developing and studying products to prevent preterm birth. Within the workshop speakers will cover the current landscape, challenges, and perspectives on preterm birth and expert panels will discuss the ethical, regulatory, and efficacy measurement considerations for clinical development programs for products intended to prevent preterm birth.
Submit a Comment to the Docket
We encourage stakeholders to submit written comments on advancing drug development for the prevention of spontaneous preterm birth to the docket: Advancing Drug Development for the Prevention of Spontaneous Preterm Birth; Public Workshop; Request for Comments.