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Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products. `, m% [/ J# P# a: `; B) K# s
AABB's Regulatory Affairs department is developing comments on a draft guidance for industry, "Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products," announced by the FDA in a "Federal Register" notice dated July 2. The draft guidance provides recommendations to assist sponsors in designing phase one trials and some phase two trials that focus on the initial evaluations of the safety, tolerability or feasibility of investigational cellular and gene therapy products. AABB will submit comments on the draft guidance. Association members should contact AABB's Regulatory Affairs department with concerns by Oct. 25. AABB hosted a webinar on this draft guidance, which is available for purchase in AABB's Marketplace. http://www.fda.gov/downloads/Bio ... erapy/UCM359073.pdf