• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

  • Print
  • Share
  • E-mail

Search Publications



Starting Date

Ending Date

Order by

Entry Details

Wound Repair Regen 1994 Jul;2(3):155-64

Regulatory concerns in the development of topical recombinant ophthalmic and cutaneous wound healing biologics.

Stromberg K, Chapekar MS, Goldman BA, Chambers WA, Cavagnaro JA


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.

Category: Journal Article
PubMed ID: #17156106 DOI: 10.1046/j.1524-475X.1994.20304.x
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2012-11-13