Table of Contents

Table of Contents


Letter From the Editor

Original Research

Improving Eye Bank Tissue Donations in a Hospice Population

Factors associated with thickness of eye bank-prepared DSAEK graft tissue

A Nomogram for Producing Consistently Thin Posterior Lamellar Microkeratome Cuts for DSAEK

Practice-Related Material

Donor Eligibility/Suitability

Tissue Donor Eligibility Trends and Challenges

Communicable Disease Testing — 11th Annual FDA and the Changing Paradigm for HCT/P Regulation

HCTP Case Presentations: Adverse Reactions and Product Deviations

FDA & the Changing Paradigm for HCT/P Regulation

FDA & the Changing Paradigm for HCT/P Regulation


Kristin Mathes


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).


Article PDF

Fullscreen Mode