The FDA has posted a proposal to disclose certain public health and safety data involved in all new and ongoing clinical studies on gene therapy and xenotransplantation (http://www.fda.gov/ohrms/dockets/98FR/011801b.htm). The proposal is intended to ensure greater public confidence in new therapeutic technologies and make FDA policy for public access to this information compatible with those of other government agencies. Written comments may be submitted until April 18, 2001, to the Dockets Management Branch, FDA, 5630 Fishers Lane, Rockville, MD 20852.
Schwetz BA. Proposal for Public Disclosure About Clinical Trials. JAMA. 2001;285(9):1146. doi:10.1001/jama.285.9.1146-JFD10002-4-1