# Presentation: 482179

## Licensure of Apheresis Blood Products

- August 15, 2007
- Lister Hill Auditorium, NIH
- Bethesda, MD

## CBER’s Vision

- 	Protect and improve public and individual health in the United States and, where feasible, globally;
- 	Facilitate the development, approval of, and access to safe and effective products and promising new technologies; and
- 	Strengthen CBER as a preeminent regulatory organization for biologics.

**Notes:**
The Center for Biologics Evaluation and Research (CBER) uses sound science and regulatory expertise to:
1.  Protect and improve public and individual health in the United States and, where feasible, globally; 
2.  Facilitate the development, approval of, and access to safe and effective products and promising new technologies; and 
Strengthen CBER as a preeminent regulatory organization for biologics.

FDA/CBER is responsible for regulatory oversight of the U.S. blood supply. CBER works closely with other parts of the Public Health Service (PHS) to establish blood standards, and to identify and respond to potential threats to blood safety or supply and to help industry promote an adequate supply of blood and blood products. 

## Licensure of Apheresis Blood Products Workshop

- 	The purpose of this public workshop is to educate industry on the licensure requirements and license application procedures for Platelets, Pheresis, Red Blood Cells, and Plasma collected by automated cell separator devices.

**Notes:**

The goals and objectives for the workshop are:
1.  Educate industry on the licensure process for apheresis platelets, red blood cells, and plasma for transfusion.  
2.  Discuss the managed review process. 
3.  Discuss the required documents needed for a submission.
4.  Review the comparability protocol and what is required of the firm.
  Review the requirements for each apheresis instrument. 

Additionally, we asked speakers from industry to give examples of how they successfully submit to the FDA for apheresis licensure.

We have also asked Dr. Louis Katz from the Mississippi Valley Regional Blood Center to talk on his recently published paper “Frequent plateletpheresis does not clinically significantly decrease platelet counts in donors” Louis Kats M.D. et al.

## Licensure of Apheresis Blood Products Workshop Co-Sponsors

*Center for Biologics Evaluation and Research, FDA*
*HHS Office of the Secretary/Office of Public Health and Science*
*AABB*
*America’s Blood Centers (ABC)*

**Notes:**
DHHS provided the travel and transcription – Jerry Holmberg
AABB provided the compendium -  Karen Shoos Lipton 
America’s Blood Centers (ABC) provided the catering – Dr. Celso Bianco
CBER – Drs. Goodman, Epstein, and Goldsmith

## Agenda

- Welcoming Remarks, Jesse Goodman, M.D., M.P.H., FDA
- The Regulatory Paradigm and Managed Review, Alan E. Williams, Ph.D., FDA
- FDA Review of Apheresis Submissions, Judy Ellen Ciaraldi, MT (ASCP)SBB, CQA (ASQ), FDA
- Top Ten Pitfalls with Submissions, Rosia E. Nesbitt, B.S. (ASCP) SBB, CQA (ASQ), FDA

## Agenda

- Examples of Successful Submissions
- 	Preparing Apheresis License Submissions                                   Stephen Kassapian, American Red Cross
- 	Blood Systems’ Licensure of 5 and 7-Day Platelets, Kathleen Hopping, B.S., CQA (ASQ), Blood Systems, Inc.
- FDA Guidance on Collection of Platelets by Automated Methods,  Lore Fields, MT (ASCP) SBB, FDA

## Agenda

- 	Impact of Very Frequent Plateletpheresis on Donor Platelet Counts,  Louis M. Katz, M.D., Mississippi Valley Regional Blood Center

## Agenda

- Failure Investigations of Apheresis Blood Products
- 	FDA Regulations and Recommendations for Failure Investigations, Hoi-may Wong, B.S., MT (ASCP) SBB, FDA
- 	Experiences with a Failure Investigation Program for Apheresis Blood Products, Faye Kugele, M.S., MT (ASCP) SBB, CQM (ASQ), American Red Cross

## Agenda

- Meet Your FDA Consumer Safety Officer

## Agenda

- Device Manufacturer’s Forum
- 	Merilyn Wiler, MT (ASCP) SBB, Gambro BCT
- 	Sharyn Orton, Ph.D., Fenwal
- 	Sue Finneran, Haemonetics
- Frequently Asked Questions and Answers, Panel of FDA staff

## Licensure of Apheresis Blood Products Workshop

- Workshop Planning Committee:
- Celso Bianco, M.D., ABC
- Sue Finneran, Haemonetics
- Joe Giglio, M.S., MT(ASCP)SBB, AABB
- Steve Kassapian, ARC
- Sharyn Orton, Ph.D., Fenwal, Inc
- Merilyn Wiler, MT(ASCP)SBB, Gambro BCT

**Notes:**
This is the list of the 6 non-FDA people on the planning committee to thank.  

## Workshop Planning Committee:
Alan Williams, Ph.D., Associate Director, Regulatory Affairs
Elizabeth Callaghan, Acting Director, Division of Blood Applications
Jennifer Scharpf, OBRR Associate Director for Policy
Rhonda Dawson, Policy Analyst
Lore Fields MT(ASCP)SBB, Consumer Safety Officer, Blood and Plasma Branch
Rosia Nesbitt MT(ASCP)SBB, Consumer Safety Officer, Blood and Plasma Branch
Hoi-May Wong MT(ASCP), Consumer Safety Officer, Blood and Plasma Branch 

- Alan Williams, Ph.D., Associate Director, Regulatory Affairs
- Elizabeth Callaghan, Acting Director, Division of Blood Applications
- Jennifer Scharpf, OBRR Associate Director for Policy
- Rhonda Dawson, Policy Analyst
- Lore Fields MT(ASCP)SBB, Consumer Safety Officer, Blood and Plasma Branch
- Rosia Nesbitt MT(ASCP)SBB, Consumer Safety Officer, Blood and Plasma Branch
- Hoi-May Wong MT(ASCP), Consumer Safety Officer, Blood and Plasma Branch