What's New in Regulatory Science - Summer 2019

Brought to you by the Office of Translational Sciences (OTS) in collaboration with the Office of Communications (OCOMM) in the Center for Drug Evaluation and Research (CDER).   What’s New in Regulatory Science is a quarterly newsletter from the Food and Drug Administration’s Center for Drug Evaluation and Research. It includes new developments, opportunities, and initiatives in regulatory science, with the goal of advancing medical product development.   Please share this message and the sign-up link with colleagues, and if you have comments or questions, contact us at OTSCommunications@fda.hhs.gov.

HIGHLIGHT

SHEDDING NEW LIGHT ON SUNSCREEN ABSORPTION

In a recent installment of the series FDA Voices, CDER Director Dr. Janet Woodcock, and Dr. Teresa Michele, Director of  CDER’s Division of Nonprescription Drug Products in the Office of New Drugs, comment on the results of an exploratory maximal usage trial (MUsT) evaluating the systemic absorption (through the skin and into the body) of sunscreen active ingredients using four commercially available sunscreen products applied under maximal use conditions. Results from the  trial, which was led by researchers at the Division of Applied Regulatory Science in the Office of Translational Sciences’ Office of Clinical Pharmacology,  are available in a  preliminary communicationin the May 6, issue of the Journal of the American Medical Association.  Drs. Woodcock and Michele also discuss a proposed rule to update regulatory requirements for sunscreen products according to the latest scientific standards.