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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation -- Enduring Material

Step Status
Educational Content
Posttest
Evaluation
Starts On: Wed, 11/16/22: 12:00 AM EST
Ends On: Sun, 10/27/24: 12:00 AM EDT
Type: Enduring Material
Credits: 1
Description: As you learned in the previous session, the FDA implemented a new pregnancy and lactation labeling system starting in 2015. Although the new labeling system improved the presentation of information in prescription medication labeling, it highlighted the gaps in human data and the need for adequate human data regarding the use of prescription medication in pregnant and lactating individuals. This presentation will provide an overview of 1.) the types of studies that are enrolling pregnant and lactating individuals, 2.) the work that FDA is doing to advance research in pregnant and lactating individuals, and 3.) information on how providers can become involved in advancing research in pregnant and lactating individuals.
Objectives:
  • Describe the data gaps that exist regarding the use of medications in pregnant and lactating individuals.
  • Discuss FDA efforts to advance research in pregnant and lactating individuals.
  • Describe types of studies that are currently enrolling pregnant and lactating individuals.
  • Examine how healthcare providers can become involved and have an impact in advancing research in pregnant and lactating individuals.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: SLIDES