Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
FDA is announcing the availability of a document entitled “Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products” dated September 2009. The guidance document provides recommendations to manufacturers, sponsors, and clinical investigators involved in the transplantation of allogeneic pancreatic islet cell products for clinical investigations of the treatment of type 1 diabetes mellitus. The guidance identifies the types of data and information that may be obtained during investigational new drug studies to assist in establishing the safety, purity, and potency of a biological product in a BLA. However, the guidance is not intended to identify all of the product, preclinical, and clinical data that may be needed to successfully support a BLA.
The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
The guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 211 has been approved under 0910-0139; the collections of information in 21 CFR part 312 has been approved under 0910-0014; the collections of information in 21 CFR parts 601 and 610 have been approved under 0910-0338; and the collections of information in 21 CFR part 1271 has been approved under 0910-0543 and 0910-0559.
Interested persons may, at any time, submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the guidance at either