- September 10, 2018
The Food and Drug Administration (FDA) held a public workshop to discuss the current state and future directions for collection of human data on the potential skin toxicity with the use of medications applied topically. The workshop will review current approaches to the collection of human data during clinical development of topical drug products. The workshop addressed the impact of human skin toxicity studies on drug labeling and consider alternative approaches to providing information about skin toxicity.
The premarket safety profile for topical drug products is supported by studies in animals and humans. In addition to adverse event information in clinical trials, human data for dermal toxicity are generated through dedicated studies to solicit potential irritancy, contact sensitization, phototoxicity, or photoallergenicity of the topical drug product. Although these safety studies on skin toxicity in humans have been typically included in the portfolio of clinical data submitted to support marketing applications, inclusion of their data in product labeling to help the prescriber is infrequent. FDA is holding this public workshop to obtain input on the complex scientific and regulatory issues relating to the conduct, interpretation, and utility of these studies. This input will aid FDA in planning future directions for the use of such studies.
This website will be updated as meeting materials are developed.
Workshop Date and Time
Monday, September 10, 2018
8:30 a.m. to 4:00 p.m., EDT
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
the Great Room (Rm. 1503, Section A)
Silver Spring, MD 20993-0002
The entrance for public hearing participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to Public Meetings at the FDA White Oak Campus.
- Federal Register Notice
- Agenda (PDF - 58 KB)
- 01 Ko Status of Human Dermal Safety Testing (PDF - 239KB)
- 02 Hill Nonclinical Aspects of Dermal Safety Testing (PDF - 83KB)
- 03 Lindstrom Labeling Issues (PDF - 631KB)
- 04 Graeber Dermal Safety Studies (PDF - 142KB)
- 05 "D. Grimes & J. Lyssikatos on Human Dermal Safety Testing for Topical Drug Products"(PDF - 1116 KB)
- 06 Wilkin Rethinking Premarketing Risk Assessment (PDF - 165KB)
- 07 Belsito In Vitro Methodologies (PDF - 299KB)
- 08 Nash (PDF - 1819KB)
- Nagao Mechanisms of Foreign Antigen (PDF - 22609KB)
A written transcript of the hearing will be made available in the public docket.
A written transcript of the hearing will be made available in the public docket. To view the webcast for this meeting, click the links below:
You may submit comments relating to the public workshop. See instructions in the Federal Register Notice for the submission of comments.
Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight EDT of October 10, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, FDA-2018-N-2582 in the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
If you have questions about the public workshop, contact Tisha Washington via email email@example.com.
|Human Dermal Safety Testing for Topical Drug Products||pdf (1.12 MB)|
|Integrated Safety Testing and Assessment of Topical Drug Products||pdf (1.78 MB)|