Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

I. Introduction II. Background III. Recommendations for Testing Donors of HCT/Ps IV. Implementation V. References Footnotes Reference Information: About this guidance document How to comment on this document To obtain copies of this document For questions regarding this document FDA office that authored this guidance October 2013 Return to Table of Contents II. BACKGROUND A. Regulatory Background…

Guidance for Industry and FDA Staff: IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System

Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or e-mail [email protected], or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. For questions on the content of this guidance, contact OCOD at the phone numbers or…

Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products

Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader® Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD) (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or…

Officer/ Employee List for STN 125478/0, RAGWITEK

DEPARTMENT OF HEALTH HUMAN SERVICES                                                     Public Health Service    EMPLOYEE/OFFICER LIST MEMO To:                              The FileDate:                           April 15, 2014 BLA:                           STN 125478/0            Sponsor:                      Merck Sharp Dohme Corp.Product:                      RAGWITEK, Short Ragweed Pollen Allergen Extract, Tablet for Sublingual Use From:                          CDR Elizabeth Valenti, MPH, REH/RS, RAC (U.S.)Signature:                   Section 916 of the Food and Drug Administration…

Influenza Virus Vaccine for the 2009-2010 Season

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Summary Basis for Regulatory Action

 Summary Basis for Regulatory Action   1.     Introduction Biogen Idec, Inc. (Biogen)has submitted an original biologics license application (BLA) to seek US licensure for Coagulation Factor IX (Recombinant), Fc Fusion Protein. The intended commercial product is a lyophilized powder in a crimp-sealed, stoppered, glass vial, available in nominal dosage strengths of 500, 1000, 2000 or…

August 23, 2010 Approval Letter – Engerix

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June 2, 2010 Approval Letter

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December 23, 2010 Approval Letter – Engerix

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