Public Workshop on Measurement Methods for Hemoglobin and Iron Stores in Blood Donors

Public Workshop on Measurement Methods for Hemoglobin and Iron Stores in Blood DonorsThe objective of this workshop is to discuss how current hemoglobin qualification standards and interdonation intervals affect donor health and blood availability, measurement of hemoglobin and iron stores, and mitigation of iron deficiency in blood donors.This workshop contributes to public heath since it explores whether current science and regulation ensures blood donor safety and an adequate blood supply.The public workshop served as a forum for discussion of hemoglobin and hematocrit donation standards, current methods for hemoglobin measurement, iron loss and iron measurement methods in blood donors, and strategies to maintain adequate donor iron stores. The workshop included presentations and panel discussions from experts knowledgeable in the field from academic institutions, government Agencies, and industry. The information derived from this workshop will be considered when developing policy and guidance modifications. A transcript of the workshop has been posted on the FDA website, at the following link: http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM281477.pdf

COMPLETED

ON TRACK

A. Identify planning committee

2/1/2011

Completed

1/28/2011

B. Identify co-sponsors

3/1/2011

Completed

2/28/2011

C. Draft agenda

5/1/2011

Completed

4/8/2011

D. Confirm speakers

6/1/2011

Completed

5/19/2011

E. Publish Federal Register notice

9/1/2011

Completed

8/17/2011

F. Conduct workshop

11/8-9/2011

Completed

11/9/2011

G. Evaluate workshop and plan next steps

12/15/2011

Completed

12/12/2011

H. Provide a published transcript of the workshop

1/15/2012

Completed

11/29/2011

Molecular EpidemiologyMolecular epidemiology is a branch of medical science that focuses on the contribution of potential genetic and environmental risk factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations.

http://www.fda.gov/AboutFDA/Transparency/track/ucm206349.htmFDA-TRACK CBER Research and Review Offices Dashboardhttp://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM281477.pdfHemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors Public Workshop