Speaker Abstract: S-39
Regulatory Implication of Experimental Data
Paul C. Brown, Ph.D., Center for Drug Evaluation & Research/FDA
The Center for Drug Evaluation and Research recommends, reviews and uses photosafety testing of drug products (testing for adverse effects of drug products in the presence of light). The Center published a guidance for industry on photosafety testing of drug products. This guidance represents the agency's current thinking on this topic. This guidance is intended to help applicants decide whether they should test for photoirritation and assess the potential of their drug product to enhance UV-associated skin carcinogenesis. The guidance describes a consistent, science-based approach for photosafety evaluation of topically and systemically administered drug products. The Center approach to photosafety testing permits flexibility and the Center welcomes proposals from drug sponsors on the latest scientifically sound methods for evaluating photosafety issues. Sponsors have conducted several types of photosafety tests and have proposed several alternative methods to date. Once the Center receives and reviews results of photosafety studies, the information can be incorporated into materials that communicate risks to patients, such as product labeling. In some cases, such as with sunscreen drug products, the outcome of photosafety studies may have an impact on regulatory decisions.
2004 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA
Last updated on 2004-MAY-28 by frf