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FDA is announcing the availability of a draft document entitled “Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,” dated November 2012. The draft guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products regulated by OCTGT. The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, and xenotransplantation. The guidance is intended to clarify current expectations regarding the preclinical information that supports an IND and a BLA for these product areas.
The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic.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 requirement of the applicable statutes and regulations.
This draft guidance refers to previously approved collections of information found in FDA regulations.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 312 has been approved under 0910-0014; the collections of information in 21 CFR part 601 has been approved under 0910-0338; and the collections of information in 21 CFR part 58 has been approved under 0910-0119.
The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see
Persons with access to the Internet may obtain the draft guidance at either