February 23, 2015
Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA-2014-D-1856 “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry”
Dear Dockets Manager,
AABB appreciates the opportunity to comment on “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry”. The draft guidance document provides clarification on FDA’s thinking with respect to regulatory considerations for manufacture and use of HCT/Ps from adipose tissue. This clarification will be especially helpful to sponsors, clinicians, and other establishments that manufacture and use HCT/Ps from adipose tissue. We are grateful that the Agency has taken the step of publishing a draft guidance and we look forward to a finalized version.
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.
The Center for Cellular Therapies appreciates the opportunity to comment on the draft guidance. Should you have any questions regarding these comments or would like additional information, please contact me at firstname.lastname@example.org.
Naynesh Kamani, MD
Vice President, Center for Cellular Therapies & Research