In 2017 the 21st Century Cures Act established the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) to advise the Secretary of Health and Human Services regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. PRGLAC is tasked with identifying these gaps and will report its findings back to the Secretary.
Four PRGLAC meetings were scheduled. The third meeting took place February 26-27, 2018. Dr. Kathy Wisner attended the meeting and read a brief statement on behalf of both the Teratology Society and our sister society OTIS. Additionally, the Teratology Society submitted detailed comments to the docket. Members involved in the development of the Teratology Society comments include Sue Makris, Melissa Tassinari, Alan Hoberman, Tacey White, Dana Shuey, Linda Roberts, Dinesh Stanislaus, and Christina Carruthers, and reflect review and approval by the Teratology Society Council.
Both documents are available in the Files of Interest library on BDR Connection for Teratology Society members' reference. Also included in this folder is the ILSI HESI comments which were submitted in August 2017 and are referenced in the Teratology Society comments.
For further information about PRGLAC, please refer to the website: https://www.nichd.nih.gov/About/Advisory/PRGLAC