Meeting Summary Cover Letter - Isoplate Solution
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Our Reference: CRMTS #8012 Division of Blood Applications
Ref. # BN090067 Telephone: (301) 827-3524
B. Braun Medical Inc.
Attention: Rebecca A. Stolarick
901 Marcon Boulevard
Allentown, PA 18109
Dear Ms. Stolarick:
Attached is a copy of the memorandum summarizing your June 30, 2011 Type A meeting with CBER. This memorandum constitutes the official record of the meeting. If your understanding of the outcomes differs from those expressed in this meeting summary, it is your responsibility to bring these discrepancies to CBER’s attention for resolution.
If you have any questions, please contact Iliana Valencia, Regulatory Project Manager, at (301) 827- 6161.
Alan E. Williams, Ph.D.
Associate Director for Regulatory Affairs
Acting Chief, Regulatory Project
Office of Blood Research and Review
Center for Biologics
Evaluation and Research