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Center for Biologics Evaluation and Research (U.S.)
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1
Center for Biologics Evaluation and Research annual report FY
by
Center
for
Biologics
Evaluation
and
Research
(
U
.S.)
Description: volumes : illustrations ; 28 cm.
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Microfilm
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2
Report to the biologics community
by
Center
for
Biologics
Evaluation
and
Research
(
U
.S.)
Description: volumes : illustrations ; 28 cm.
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3
FY ... report from the director
by
Center
for
Biologics
Evaluation
and
Research
(
U
.S.),
Published: U.S. Food and Drug Administration, [Center for Biologics Evaluation and Research], 2012
Description: 1 online resource (volumes)
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4
Annual report
by
Center
for
Biologics
Evaluation
and
Research
(
U
.S.)
Published: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 2011
Description: 1 online resource (volumes)
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5
Guidance for industry bar code label requirements, questions and answers
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2006
Description: ii, 9 pages : digital, PDF file.
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6
Guidance for industry how to comply with the Pediatric Research Equity Act
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005
Description: 18 pages : digital, PDF file.
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7
Guidance for industry Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of human cells, tissues, and cellular and tissue based products (HCT/Ps)
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2009
Description: i, 59 pages : digital, PDF file.
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8
Guidance for industry potency tests for cellular and gene therapy products
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2008
Description: i, 15 pages : digital, PDF file.
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9
PDUFA pilot project proprietary name review
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], 2008
Description: 38 pages : digital, PDF file.
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10
Guidance for industry characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and...
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2006
Description: ii, 49 pages : digital, PDF file.
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11
Guidance for industry implementing a collection program for source plasma containing disease-associated and other immunoglobulin G (IgG) antibodies
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2006
Description: i, 4 pages : digital, PDF file.
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12
Guidance for industry preparation of IDEs and INDs for products intended to repair or replace knee cartilage
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, 2007
Description: i, 16 pages : digital, PDF file.
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13
Guidance for industry providing regulatory submissions to the Center for Biologics Evaluation and Research (CBER) in electronic format, lot release protocols
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007
Description: i, 6 pages : digital, PDF file.
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14
Guidance for industry recommendations for obtaining a labeling claim for communicable disease donor screening tests using cadaveric blood speciments from donors of human cells, tis...
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2004
Description: i, 7 pages : digital, PDF file.
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15
Guidance for industry use of nucleic acid tests on pooled and individual samples from donors of whole blood and plasma components (including source plasma and source leukocytes) to...
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2004
Description: i, 11 pages : digital, PDF file.
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16
Guidance for industry how to complete the vaccine adverse event reporting system form (VAERS-1)
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 1998
Description: 15 pages : digital, PDF file.
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17
Guidance for industry notifying FDA of fatalities related to blood collection or transfusion
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2003
Description: 5 pages : digital, PDF file.
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18
Guidance for industry pre-storage leukocyte reduction of whole blood and blood compoments intended for transfusion
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2001
Description: i, 22 pages : digital, PDF file.
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19
Guidance for industry precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and the...
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 1999
Description: i, 9 pages : digital, PDF file.
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20
Guidance for industry drug-induced liver injury, premarketing clinical evaluation
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2009
Description: 1 online resource (25 pages)
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