Title: Division of Emerging and Transfusion Transmitted Diseases Hira L. Nakhasi, Ph.D. Director, DETTD Author: CBER Last modified by: CBER Created Date
Conducting periodic workload assessments to address any imbalances in a timely fashion ... control of an expanding number of known and emerging transfusion ...
Supplemental Testing of Donors for HIV and HCV September 18, 2003 BPAC Meeting Robin Biswas, M.D. Indira Hewlett, Ph.D. FDA/CBER/OBRR/DETTD Supplemental Testing of ...
Classification of HLA Devices FDA Introduction & Background Sheryl A. Kochman CBER/OBRR/DBA Objectives Provide an overview of the current regulatory status of HLA ...
Critical Path Initiative Workshop: OBRR Summary. Paul A. Mied, Ph.D. ... Critical Path: Example of Success. Donor Screening for West Nile Virus RNA ...
Hira Nakhasi, Ph.D. Director July 13, 2006 Division of Emerging and Transfusion Transmitted Diseases (DETTD)/OBRR/CBER Mission Proactively ensuring the safety of the ...
Clinical research. Blood collection. Industry. OBRR Intramural Research Review ... Review intent: Overarching summary of research program's goals and support ...
Licensed Biological Products with Structural Heterogeneity. Andrew C. Chang, Ph.D. ... Andrew Chang, Ph.D. OBRR/CBER. Recombinant products and monoclonal antibodies ...
Virology. Indira K. Hewlett, Ph.D. Laboratory of Hepatitis & Related ... Laboratory of Molecular Virology. Indira Hewlett, Chief. Hewlett Lab. Lee, S. Wood, O ...
... Transfusion-Transmitted vCJD in recipients of non-leukoreduced red cell concentrates from donors who developed vCJD 2 cases of clinical vCJD Donors developed ...
Anti- HIV-1/2, HIV-1 p24 Ag ,anti-HCV, HBsAg , anti HBc, anti-HTLV-1/2, syphilis ... Summing reduction factors to give a total log10 reduction value (LRV) ...
Topic 4 Bacterial and Fungal Contamination of Human Tissue Intended ... reports of bacterial and fungal contamination of musculoskeletal tissue allografts ...
Paradigm: Validation of Virus Removal/inactivation Includes: Scaling down process steps ... Membrane-free infectious material (e.g. fibrils) Blood and blood fractions ...
Enhances likelihood of surveillance and investigation of measles cases in PIDD patients. Provides information about measles exposure considerations in package insert .
American Red Cross objectively assessed 550 systemwide probable TRALI cases (2003-2005) ... American Red Cross Experience with TRALI. Richard Benjamin, M.D. ...
Two months of irradiation records. Most recent dosimetry map. Contractor information, if applicable. Contractor who performs irradiation must register with FDA ...
Cell Lines. Virus Genome Size(nm) Enveloped Resistance. MVM ss-DNA 18-26 No Very high ... At least one step should be effective against non-enveloped viruses ...
Donor Suitability and Blood and Blood Product Safety in Cases of Known or ... for the Assessment of Donor Suitability and Blood and Blood Product Safety ...
Diary cards and weekly telephone calls also collected information on HAE attacks ... SD. 5.43. 4.80. Median. 6.0. 13.5. Min. 0. 6. Max. 17. 22. Prophylaxis: Results ...
PMA supplement definitions, modular PMA fees, BLA and Efficacy supplement ... New document courier service. Close collaboration with CDRH. Least Burdensome training ...
Manufacturing (CGMP) in Investigational Products NIAID/ NIH April 15, 2005 Chris Joneckis, Ph.D. Senior Advisor For CMC Issues Center For Biologics Evaluation And ...
Division of Hematology Emergency Preparedness Action Initiatives. Prepared by ... Facilitate accessibility of supplies for civilians. Discussions with CDC, DoD and NIH ...
Contain membrane phospholipids and express antigens ... Violet Wright, RN, DNSc. NIH CC. Department of Transfusion Medicine. USUHS. Olga Simakova, MS ...
Probability of exposure to infected cow in 2003. 1 positive identified 35 million slaughtered ... And / or. Dilution of ID50s from 1 cow in a batch of AMR ...
BLAs, PMAs, INDs, IDEs, 510(k)s for blood screening and diagnostic testing for ... expert scientific and technical advice to other Agency and Government ...
Anti-HBc collections allowed in this category only when donor is known to also have Anti-HBs ... If implemented at more than one facility, submit a list of ...
Reported for anion exchange, cation exchange, hydrophobic interaction, and ... Some chromatographic resins (e.g. some anion, cation) may be washed with 0.1-1 M ...
Vostal 10/2005. C B. E R. Labeling Claims for TSE Reduction Studies with Blood ... Schalm, O.W. Veterinary Hematology, 2nd ed. Lea & Febiger, Philadelphia 1965 ...
... on product availability for Primary Humoral Immune Deficiency Diseases (PIDD) ... patients, especially those with combined humoral and T cell deficiencies, are ...
... Use of Sterile Connecting Devices in Blood Bank Practices, 11/22/2000 ... Donor suitability, including donor deferral, donation interval (eg, RBC loss) ...
Title: Vaccinia Immune Globulins: Characteristics, Supply, Clinical Use and Licensure Author: scottd Last modified by: Dot Scott Created Date: 5/1/2002 7:49:42 PM
Advanced age is by far the most significant risk factor for severe neurologic disease ... Prevalence of viremia (viral load, IgM antibody, virus culture status) ...
Surveillance of HIV variants in Cameroon and evaluation of their impact on HIV diagnostics Indira K. Hewlett, Ph.D Chief, Laboratory of Molecular Virology, CBER, FDA
FDA seeks advice on its approach to assessing the possible transfusion risk from ... seropositive for SFV originating from chimpanzees; all 4 individuals handled non ...
Manufacturing processes must contain at least two orthogonal and effective steps ... Cretin common inactivation methodologies (s/d and heat) that have been used by ...
... for quality control (QC) testing of apheresis platelets (Pall, bioMerieux) ... tested with a culture-based bacterial detection device (QC indication) (Pall) ...
Photo credit, Susan Wong. 2. OCTGT Office Site Visit, Report, and ... Explicit research priorities, horizon scanning, annual program reporting and assessment ...
... which a firm does not presently hold a license and is not requesting licensure. FDA only approves labels for a firm's licensed products. 16. C. B. E. R ...
Report of the Task Force to the FDA Blood Products Advisory Committee. December ... the Blood Donor History Questionnaire' sponsored by FDA, CBER, ABRA and AABB ...