May 7, 2010 VIA FACSIMILE AND CERTIFIED MAIL RETURN RECEIPT REQUESTED John P. Barry, Ph.D. Drug Regulatory Affairs Novartis Vaccines and Diagnostics, Inc. 350 Massachusetts Avenue Cambridge, MA 02139 Re: Menveo [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] BLA STN# 125300 Dear Dr. Barry: The Office of Compliance and Biologics…
Patient Touch™ Blood Product Administration System v3.2.1
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Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry
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Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271
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Flebogamma DIF 5% & 10%
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Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2016
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October 27, 2015 Approval Letter
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Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents
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Order to Cease Manufacturing and to Retain HCT/Ps
August 18, 2006 HAND DELIVERED Philip GuyettOwnerDonor Referral Services4724 Hargrove RoadRaleigh, NC 27616 Dear Mr. Guyett: The Food and Drug Administration (FDA or the agency) conducted an inspection of your establishment, Donor Referral Services (DRS or Establishment), at 4724 Hargrove Road, Raleigh, North Carolina 27616, which manufactures human cells, tissues, and cellular and tissue-based products…
Approval History, Letters, Reviews, and Related Documents
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