Labels Without Categories: A Workshop on FDA’s Pregnancy and Lactation Labeling Rule

  • Start Date/Time :
  • End Date/Time :
  • Location : Arlington, Virginia, USA


The recently finalized Pregnancy Labeling and Lactation Labeling Rule changes the organization of the current Pregnancy and Nursing Mothers section of the US package insert of prescription drugs. In response to these changes in prescription drug labeling, the HESI Developmental and Reproductive Toxicology (DART) Technical committee sponsored a two-day workshop on this topic.

This workshop aimed to:

(1) provide a forum to discuss the impact of the PLLR;
(2) train relevant industry professionals on how to write labels according to the new rule;
(3) provide feedback to the US FDA.

The final workshop program is available here.

Workshop Sessions

Please contact Mr. Oscar Bermudez ( for addtional information.

Contact Us

Health and Environmental Sciences Institute (HESI)
Phone: +1-202-659-8404
Fax: +1-202-659-3859

740 15th Street NW, Suite 600
Washington, DC 20005

Stay Informed

Sign up for our monthly e-newsletter.