title: Regulatory concerns in the development of topical recombinant ophthalmic and cutaneous wound healing biologics.
abstract: The use of recombinant DNA technology has enabled the development of an increasing number of endogenous growth regulatory peptides for potential use as therapeutic biologics. Numerous such recombinant peptides are now licensed, and many are in various stages of pharmaceutical development. Although currently there are a number of "Points to Consider" and related guidance documents available concerning various issues of biotechnology-derived products, the purpose of this article is to focus on the use of these biologics in topical ophthalmic and chronic cutaneous wound healing. Regulatory expectations with respect to product quality, safety, and efficacy that may be particularly germane to these products will be discussed. Providing regulatory guidance on these issues may not only facilitate the introduction of safe and effective new biologic therapies into clinical trials at the investigational level but also provide appropriate information to aid in their eventual approval for licensure and widespread clinical use.
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Adminstration, Rockville, MD, USA.
authors.forename: K
authors.initials: K
authors.lastname: Stromberg
authors.forename: M S
authors.initials: MS
authors.lastname: Chapekar
authors.forename: B A
authors.initials: BA
authors.lastname: Goldman
authors.forename: W A
authors.initials: WA
authors.lastname: Chambers
authors.forename: J A
authors.initials: JA
authors.lastname: Cavagnaro