Table of Contents
FDA & the Changing Paradigm for HCT/P Regulation
EBAA, Medical Standards, labeling, tissue report form, package insert form, preservation type, processing type, predistribution shipment
The Pharmaconference, Inc. hosts annual cellular and tissue conferences. The 11th Annual FDA and Changing Paradigm for HCT/P Regulations, held March 23-25, 2015, included presentations from FDA and industry on labeling and accompanying record requirements for cells, and musculoskeletal and ocular tissues. The FDA gave a general session presentation detailing requirements according to 21 CFR 1271. During breakout sessions, industry speakers from cells and musculoskeletal and ocular tissues gave presentations describing their industry specific requirements, i.e., according to their respective accreditation bodies. The content here is the presentation given for requirements of eye banks accredited by the Eye Bank Association of America (ocular tissue).