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Results 1 - 50 of 305  for Bainbridge State College

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1
Material Type:
Book
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Guidance for industry : availability of licensed donor screening tests labeled for use with cadaveric blood specimens.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2000

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2
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Book
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Guidance for industry for platelet testing and evaluation of platelet substitute products.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1999

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3
Material Type:
Book
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PDUFA pilot project : proprietary name review.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2008

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4
Material Type:
Book
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Guidance for industry in the manufacture and clinical evaluation of in vitro tests to detect nucleic acid sequences of human immunodeficiency viruses types 1 and 2.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1999

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5
Material Type:
Book
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Guidance for industry : testing limits in stability protocols for standardized grass pollen extracts.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2000

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6
Material Type:
Book
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Guidance for industry : clinical data needed to support the licensure of seasonal inactivated influenza vaccines.

Center for Biologics Evaluation and Research (U.S.)

Washington, D.C. : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2007

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7
Material Type:
Book
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Guidance for industry considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2006

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8
Material Type:
Book
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Guidance for industry : year 2000 date change for computer systems and software applications used in the manufacture of blood products.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1998

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9
Material Type:
Book
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General principles of software validation : final guidance for industry and FDA staff.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research 2002

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10
Material Type:
Book
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Guidance for reviewers : potency limits for standardized dust mite and grass allergen vaccines, a revised protocol.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2000

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11
Material Type:
Book
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Guidance for industry : how to comply with the Pediatric Research Equity Act.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : 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

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12
Material Type:
Book
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Guidance for industry : guidance for human somatic cell therapy and gene therapy.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1998

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13
Material Type:
Book
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Guidance for industry for the submission of chemistry, manufacturing and controls and establishment description information for human blood and blood components intended for transfusion or for further manufacture and for the completion of the form FDA 356h "Application to market a new drug, biologic or an antibiotic drug for human use."

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1999

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14
Material Type:
Book
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Guidance for industry : drug-induced liver injury, premarketing clinical evaluation.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : 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

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15
Material Type:
Book
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Guidance for industry : potency tests for cellular and gene therapy products.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2008

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16
Material Type:
Book
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Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs, questions and answers.

Center for Biologics Evaluation and Research (U.S.)

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research 2008

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17
Material Type:
Book
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Guidance for industry : clinical data needed to support the licensure of pandemic influenza vaccines.

Center for Biologics Evaluation and Research (U.S.)

Washington, D.C. : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2007

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18
Material Type:
Book
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Guidance for industry : precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and their contacts.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1999

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19
Material Type:
Book
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Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs).

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2008

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20
Material Type:
Book
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Guidance for industry : submitting type V drug master files to the Center for Biologics Evaluation and Research.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2001

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21
Material Type:
Book
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Guidance for industry : regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) : small entity compliance guide.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2007

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22
Material Type:
Book
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Guidance for industry : assessing donor suitability and blood and blood product safety in cases of known or suspected west Nile virus infection.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2005

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23
Material Type:
Book
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Guidance for industry : an acceptable circular of information for the use of human blood and blood components.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2003

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24
Material Type:
Book
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Guidance for industry : cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs).

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2007

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25
Material Type:
Book
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Guidance for industry and FDA review staff : collection of platelets by automated methods.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2007

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26
Material Type:
Book
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Guidance for industry : revised recommendations for donor and product management based on screening tests for syphilis.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2003

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27
Material Type:
Book
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Guidance for industry : gene therapy clinical trials, observing subjects for delayed adverse events.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2006

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28
Material Type:
Book
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Guidance for industry : implementation of acceptable full-length donor history questionnaire and accompanying materials for use in screening donors of blood and blood components.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2006

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29
Material Type:
Book
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Guidance for industry : eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2007

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30
Material Type:
Book
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Guidance for industry : informed consent recommendations for source plasma donors participating in plasmapheresis and immunization programs.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2007

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31
Material Type:
Book
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Guidance for industry : criteria for safety and efficacy evaluation of oxygen therapeutics as red blood cell substitutes.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2004

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32
Material Type:
Book
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Guidance for industry : changes to an approved application : biological products, human blood and blood components intended for transfusion or for further manufacture.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2001

Online access

33
Material Type:
Book
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Guidance for industry : precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and their intimate contacts.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2002

Online access

34
Material Type:
Book
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Guidance for industry : FDA review of vaccine labeling requirements for warnings, use instructions, and precautionary information.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2004

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35
Material Type:
Book
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Guidance for industry : considerations for allogeneic pancreatic islet cell products.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2008

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36
Material Type:
Book
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Guidance for industry : MedWatch form FDA 3550A, mandatory reporting of adverse reactions related to human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2005

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37
Material Type:
Book
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Guidance for industry : source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2003

Online access

38
Material Type:
Book
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Guidance for industry : preparation of IDEs and INDs for products intended to repair or replace knee cartilage.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : 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

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39
Material Type:
Book
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Guidance for industry and FDA staff : class II special controls guidance document : automated blood cell separator device operating by centrifugal or filtration separation principle.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2007

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40
Material Type:
Book
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Guidance for industry : revised recommendations for the assessment of donor suitability and blood product safety in cases of suspected severe acute respiratory syndrome (SARS) or exposure to SARS.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2003

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41
Material Type:
Book
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Guidance for industry : biological product deviation reporting for blood and plasma establishments.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2006

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42
Material Type:
Book
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Guidance for industry : compliance with 21 CFR part 1271.150(c)(1), manufacturing arrangements.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2006

Online access

43
Material Type:
Book
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Guidance for FDA reviewers : premarket notification submissions for transfer sets (excluding sterile connecting sets).

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2001

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44
Material Type:
Book
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Guidance for industry : recognition and use of a standard for uniform blood and blood component container labels.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2006

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45
Material Type:
Book
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Guidance for industry on the content and format of chemistry, manufacturing and controls information and establishment description information for an allergenic extract or allergen patch test.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1999

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46
Material Type:
Book
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Guidance for industry : public health issues posed by the use of nonhuman primate xenografts in humans.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1999

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47
Material Type:
Book
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Guidance for industry : efficacy studies to support marketing of fibrin sealant products manufactured for commercial use.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1999

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48
Material Type:
Book
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Guidance for industry : errors and accidents regarding saline dilution of samples used for viral marker testing.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1998

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49
Material Type:
Book
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Guidance for industry : recommendations for donor questioning regarding possible exposure to malaria.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2000

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50
Material Type:
Book
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Guidance for industry : bar code label requirements, questions and answers.

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : 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

Online access

Results 1 - 50 of 305  for Bainbridge State College

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