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FDA News: Issue 15, June 2020

Author: [AUTHOR] Published on 6/23/2020 3:03:00 PM


FDA and University of Maryland Announce a Virtual Workshop Entitled "Topical Drug Development - Evolution of Science and Regulatory Policy 2" for July 23-24, 2020

The US 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 two-day workshop will bring together stakeholders from the FDA, academia, and industry in a virtual setting to discuss the recent advances in the assessment of dermal penetration using in vivo, in vitro, and in silico methods and models.

This workshop will build upon the success of the predecessor 2019 workshop held at the University of Maryland School of Pharmacy which was primarily focused on the use of the Maximal Usage Trial (MUsT) in dermal absorption assessment (https://www.pharmacy.umaryland.edu/centers/cersievents/topical/agenda/).

This workshop will provide an update on the topic of dermal absorption assessment in a regulatory setting. Day one of the workshop will focus on the in vitro and in silico methods and how they have been incorporated into current drug development programs along with discussion on their potential application to drug development in the future. Day two of the meeting will focus specific attention on the dermal absorption of sunscreens and topical antiseptics as a significant body of data is being generated in this area that can be used to validate and inform the in vitro methods. Additional insights from both of the FDA sunscreen studies will be presented along with how the totality of these methods (MUsT, in vitro, and in silico) can be harnessed to drive dermal drug development.

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. The program is designed to appeal to a broad audience of clinicians, drug formulators, regulators, and others.

Program 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.
The date, time, and location of the workshop are as follows:

Date: July 23-24, 2020
Time: 8:00 am - 4:30 pm (Thursday, July 23rd)

8:00 am - 4:30 pm (Friday, July 24th)

Location: This is a virtual public workshop.

For more information, including registration details, visit: www.pharmacy.umaryland.edu/topical2. For reference, the "Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations" final guidance is available at https://go.usa.gov/xmPKD. Please refer to the final guidance for more details.

If you have any additional questions about this workshop, please contact cersi@umd.edu.


The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at http://go.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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