Collaboration Details

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Title of Collaborative Activity:

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

Description of Collaborative Activity:

The 21st Century Cures Act established PRGLAC to advise the Secretary of Health and Human Services (HHS) 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. In addition to providing advice and guidance to the Secretary, the Task Force will prepare and submit to the Secretary and Congress a report that includes each of the following: a plan to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies; ethical issues surrounding the inclusion of pregnant women and lactating women in clinical research; effective communication strategies with healthcare providers and the public on information relevant to pregnant women and lactating women; and recommendations to improve the development of safe and effective therapies for pregnant women and lactating women. The report will also include identification of Federal activities, including the state of research on pregnancy and lactation; recommendations for the coordination of, and collaboration on research related to pregnant women and lactating women; dissemination of research findings and information relevant to pregnant women and lactating women to providers and the public; and existing Federal efforts and programs to improve the scientific understanding of the health impacts on pregnant women, lactating women, and related birth and pediatric outcomes, including with respect to pharmacokinetics, pharmacodynamics, and toxicities.

Type of Collaborative Activity:

Committee, Advisory Group, or Work Group

Year the Collaborative Activity Originated:

2017

NIH Participating Institutes/Centers/Office of the Director:

NCATS, NCCIH, NHLBI, NIAID, NICHD, NIDDK, NIMH, OD/DPCPSI/ORWH

HHS Agency Collaborators on this Activity:

AHRQ, CDC, FDA, HRSA, OS