Dear Mr. Stoppenbach,
I apologize for the delay. I have discussed this issue with our Office of Blood Research and Review and it appears for your purposes, we are not aware of additional publications which are relevant to your needs.
If you require specific approval information, that request must be made through the Freedom of Information Act (FOIA). Information on submitting a request under FOIA is available on our website at: fda.gov/opacom/backgrounders/foiahand.html
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration