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Notice

Guidance for Industry on Photosafety Testing; Availability

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Photosafety Testing.” This guidance provides recommendations on when to test for photoirritation and assess the potential of drug products to enhance ultraviolet (UV)-associated skin carcinogenesis.

DATES:

Submit written comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

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FOR FURTHER INFORMATION CONTACT:

Abigail C. Jacobs, Center for Drug Evaluation and Research (HFD-540), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2020.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Photosafety Testing.” This guidance provides recommendations on when to test for photoirritation and assess the potential of drug products to enhance UV-associated skin carcinogenesis.

In the Federal Register of January 10, 2000 (65 FR 1399), FDA published a notice making available a draft guidance entitled “Photosafety Testing.” The notice gave interested persons an opportunity to submit comments. As a result of the comments, certain sections of this guidance were reworded to improve clarity. This guidance further emphasizes that a flexible approach can be used to address adverse photoeffects and that a specific assay is not required. Moreover, it encourages the development of methods that can be efficiently used to evaluate human safety. This guidance describes a consistent, science-based approach for testing of topically and systemically administered drug products. It also describes basic concepts of photobiology and phototesting.

This guidance is being issued consistent with FDA's good guidance practice regulation (21 CFR 10.115). The guidance represents the agency's current thinking on nonclinical photosafety testing. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Dockets Management Branch (see ADDRESSES) written or electronic comments on the guidance at any time. Two paper copies of mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​cder/​guidance/​index.htm or http://www.fda.gov/​ohrms/​dockets/​default.htm.

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Dated: April 30, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-11216 Filed 5-6-03; 8:45 am]

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