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CBER FY 2013 Recall Posting
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Evolving Data Mining System is Designed to Speed Identification of Adverse Events Following Vaccinations
The US Food and Drug Administration (FDA) has developed a computerized text mining system that will help agency scientists quickly review reports submitted to the Vaccine Adverse Event Reporting System (VAERS) to find evidence for adverse events following vaccination. Text mining is the process by which a specially designed computer program extracts specific high-quality information…
Regulatory Submissions in Electronic Format for Biologic Products
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Draft Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies.
 Printer Friendly Version (PDF – 69KB) I. Introduction II. Discussion III. When FDA Intends to Excercise Enforcement Discretion Reference Information: About this guidance document To obtain copies of this document For questions regarding this document FDA office that authored this guidance March 2014 Return to Table of Contents Return to Table of Contents Return to…
Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus
[PDF Printable Version – 291KB] 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…
November 16-17, 2010: Vaccines and Related Biological Products Advisory Committee Briefing Document Pathway to Licensure for Protective Antigen-based Anthrax Vaccines for a Post-exposure Prophylaxis Indication Using the Animal Rule
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Summary Basis for Regulatory Action, December 22, 2013
PDF Version  1. Introduction Novo Nordisk submitted a Biologics License Application (BLA) for Coagulation Factor XIII A-Subunit (Recombinant) (rFXIII A) on February 23, 2011 (BLA 125398/0). The product was granted Orphan Product designation (designation 03-1748). The proprietary name TRETTEN was found to be acceptable. TRETTEN is presented as a lyophilized powder to be reconstituted…
November 5, 2013 Approval Letter
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Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria
I. Introduction II. Background III. Definitions IV. RecommendationsA. Donor History Questionaire B. Donor Deferral and Reentry C. Product Retrieval and Quarantine, and Notification of Consignees of Blood and Blood ComponentsD. Product Disposition and LabelingE. Reporting a Biological Product Deviation (BPD) V. Additional Considerations VI. Implementation of Recommendations VII. References Appendix Footnotes VIII. For More Information Reference Information: About…