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AABB > Resource Center > Regulatory/Government Affairs > Biologics License Applications

Biologics License Applications Checklists 

The Coalition for Blood Safety — composed of AABB, America’s Blood Centers, American Red Cross and the Armed Services Blood Program — established a task force to prepare guidelines intended to assist blood establishments in meeting the requirements for submission of a biologics license application or a license supplement. The task force researched existing FDA regulations, guidelines, memoranda and workshop publications to produce checklists of materials needed to support a submission for red blood cells, platelets and fresh frozen plasma collected by apheresis. Each checklist is intended to be a stand-alone document. When additional products are being collected concurrently, the checklist for that product should be consulted. Although the checklists have not been approved by FDA, the task force believes they are comprehensive and reflect current FDA requirements. The CFBS task force periodically reviews the checklists and makes revisions as appropriate and as recommended by FDA guidance.

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supersedes FDA’s “Revised Guideline for the Collection of Platelets, Pheresis” from October 1988 and finalizes the draft guidance “Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods,” published in September 2005.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)

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