Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation

摘要

The Food and Drug Administration (FDA) is proposing to amend the biologics licensing regulations regarding confidentiality of information. The amendments would add provisions that would make available for public disclosure, and require submission for public disclosure of, certain data and information related to human gene therapy or xenotransplantation. The proposed regulation would apply specifically to the areas of human gene therapy and xenotransplantation because these areas of clinical research have the potential for unique public health risks and modification of the human genome. The proposed rule would provide for public disclosure of certain data and information related to an investigational new drug application (IND), to provide an opportunity for public education on, and discussion and consideration of, public health and safety issues. In addition, the proposed rule would require sponsors of clinical trials on human gene therapy or xenotransplantation to submit to FDA for public disclosure certain data and information that has been redacted to remove or obscure all information defined as confidential commercial or trade secret, or names and other personal identifiers of p