The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day virtual public workshop entitled, “Topical Drug Development – Evolution of Science and Regulatory Policy 2” on July 23-24, 2020. This workshop will bring together stakeholders from the FDA, academia, and industry to discuss recent advances in the assessment of dermal absorption using in vivo, in vitro, and in silico methods and models. The program will build upon the success of the predecessor workshop in 2019.

Workshop Objectives:

  • To facilitate discussion as to the design elements and concerns of both in vivo and in vitro methods in the new drug and over-the-counter drug space.
  • To present recent advances and examples of the use of in vitro and in silico methods in the assessment of dermal absorption from both a new drugs and generic drug development perspective.
  • To provide an update on the progress on the developments in the area of sunscreen and topical antiseptic absorption.
  • To stimulate discussion between interested parties in the evolution of science in the area of topical drug development and dermal absorption testing.

Meeting Information and Registration:

This workshop is open to the public with no cost to attend, but registration is required. The workshop will be conducted live via WEBEX and arrangements will be made to capture questions via the chat feature to facilitate discussion during the round table and Q&A periods. To see the final agenda and register, visit the workshop page.

For reference, see the guidance for industry on Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations (May 2019).

For questions regarding this event, please contact:

E. Dennis Bashaw, PharmD.
Senior Science Advisor
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Phone: 301-796-1502