FDA and University of Maryland Announce Workshop Entitled “Topical Drug Development - Evolution of Science and Regulatory Policy” for July 29-30, 2019

FDA and University of Maryland Announce Workshop Entitled “Topical Drug Development - Evolution of Science and Regulatory Policy” for July 29-30, 2019

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 public workshop entitled “Topical Drug Development - Evolution of Science and Regulatory Policy” on July 29-30, 2019. This workshop will bring together stakeholders from the FDA, academia, and industry to discuss the underpinnings of the Maximal Usage Study (MUsT) program, the successful incorporation of MUsT in drug development, and the utilization of in vitro methods in product development. The assessment of dermal absorption in topical drug development is a relative new-comer to clinical pharmacology and pharmacokinetics, in general. This has historically been due to the lack of both sufficient analytical models and standardized assessment protocols. In the early 1990s, the FDA initiated the development of a MUsT paradigm designed to both assist in the evaluation of in vivo safety by providing direct assessment of plasma levels following application of topical products, and to provide information on the effects of disease and formulation on dermal penetration. Since its introduction, the MUsT paradigm has been used in the development program of every topically applied New Drug Application (NDA) in the U.S. The increased scrutiny of topical antiseptics and sunscreens has led to the adoption of the MUsT paradigm into the area on non-prescription drug products via both draft and final rules for antiseptics, a safety and effectiveness guidance for sunscreens, the draft and pending final rule for sunscreens, and the recently published final guidance for industry entitled "Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” In parallel, in vitro permeation methods have progressed to the point where they can be used, in conjunction with the in vivo MUsT paradigm, as a tool in the successful development of topical drugs. The objectives of this workshop are to: Present the background of the current regulatory policy in the area of dermal absorption and its underpinnings. Provide examples of the successful incorporation of both in vivo (MUsT) and in vitro (percutaneous permeation studies, i.e., IVPT) in drug development. 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 (OTC) drug space. Stimulate discussion between interested parties in the evolution of science in the area of topical drug development and dermal absorption testing. Additionally, data from the recent FDA publication of their pilot sunscreen MUsT program will be discussed along with how this information can be used to augment and improve the development of non-prescription drugs, both under the rubric of an NDA and the OTC Monograph system. The date, time, location, and other details of the workshop are as follows: Date: July 29-30, 2019 Time: 8:30 am – 5:00 pm Location: University of Maryland School of Pharmacy, 20 N. Pine Street, Baltimore, MD 21201 Additional information about this workshop, including registration, agenda, poster submission instructions, and parking and directions, is available at https://www.pharmacy.umaryland.edu/centers/cersievents/topical/. Registration can be accessed at https://www.eventbrite.com/e/topical-drug-development-evolution-of-science-and-regulatory-policy-tickets-62326579477. In addition to the live program, the workshop will be broadcast via a live stream webinar on July 29-30, 2019. Individuals who cannot attend the event in-person but wish to view the webinar are still required to complete registration for the conference. Registration to view the webinar is free. If you have any additional questions about this workshop, please contact cersi@umd.edu.