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Biologics License Applications Checklists

Overview

A biologics license application (BLA) is submitted by blood establishments to the Food and Drug Administration (FDA) for approval prior to distributing blood and blood components in interstate commerce, as required in 21 CFR 601.2. The BLA requests FDA approval and licensure for an establishment to collect the blood products, either individually or in combination, as described in standard operating procedures.  A license supplement to an approved BLA is required by FDA when changes are made to the establishment’s manufacturing processes in the approved BLA.

The AABB BLA checklists are intended to assist blood establishments when preparing a BLA and license supplement. The BLA checklists provide detailed information on the content and materials required in a BLA for blood and blood components.

AABB works directly with government agencies, including the FDA, by submitting comments and providing reviews of regulatory issues concerning the requirements of the BLA and IND application process. In February 2017, the AABB Regulatory Affairs Committee (RAC) began a comprehensive review process to ensure each checklist is updated consistent with current FDA regulations and guidance recommendations. As the RAC continues this comprehensive review though 2017, the updated checklists will note the date in the footer to assist you with identifying newly revised documents.

For further assistance, contact the AABB Regulatory Affairs Department at regulatory@aabb.org.

Platelets

With the release of the December 2007 guidance document “Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods,” the FDA provided revised recommendations for the collection of platelets by automated methods, or plateletphereis. Many of the changes reflect current industry practices and advances in technology. The platelets pheresis checklist has been updated to incorporate these changes. The December 2007 guidance document supersedes FDA’s “Revised Guideline for the Collection of Platelets, Pheresis” from October 1988 and finalizes the draft guidance “Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods,” published in September 2005.

The regulatory references list, used by the FDA when reviewing Platelet BLAs, is provided as an additional resource.

Platelets Pheresis Checklist (PDF)
Regulatory References List (PDF)

Red Blood Cells

The red blood cells checklist is based primarily on the February 2001 FDA document “Guidance for Industry Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods.” Additional information was derived from the FDA workshop “Licensure of Apheresis Blood Products,” held in August 2007.

Red Blood Cells Checklist (PDF)

Plasma

Infrequent plasma collections are the focus of the checklist for fresh frozen plasma. The most current FDA guidance on this topic is “Revision of FDA Memorandum of August 17, 1982: Requirements for Infrequent Plasma Donors,” which was published in May 1995.

Fresh Frozen Plasma Checklist (PDF)