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Results 1 - 50 of 305  for Bainbridge State College

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1
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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
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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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4
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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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5
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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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6
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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7
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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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8
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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9
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

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10
Material Type:
Book
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Guidance for industry : supplemental testing and the notification of consignees of donor test results for antibody to hepatitis C virus (anti-HCV).

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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11
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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12
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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13
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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14
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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15
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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16
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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17
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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18
Material Type:
Book
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Guidance for industry : use of serological tests to reduce the risk of transmission of trypanosoma cruzi infection in whole blood and blood components for transfusion and 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 2009

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19
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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20
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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21
Material Type:
Book
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Guidance for industry : general principles for the development of vaccines to protect against global infectious diseases.

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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22
Material Type:
Book
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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).

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 2009

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23
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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24
Material Type:
Book
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Points to consider in the manufacture and testing of monoclonal antibody products 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 1997

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25
Material Type:
Book
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Guidance for FDA reviewers : premarket notification submissions for empty containers for the collection and processing 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 2001

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26
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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27
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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28
Material Type:
Book
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Guidance for industry : "computer crossmatch" (electronic based testing for the compatibility between the donor's cell type and the recipient's serum or plasma type).

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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29
Material Type:
Book
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Guidance for industry : notifying FDA of fatalities related to blood collection or transfusion.

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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30
Material Type:
Book
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Guidance for industry : validation of procedures for processing of human tissues intended for transplantation.

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

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31
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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32
Material Type:
Book
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Guidance for industry : implementing a collection program for source plasma containing disease-associated and other immunoglobulin G (IgG) antibodies.

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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33
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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34
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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35
Material Type:
Book
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Guidance for industry : recommendations for obtaining a labeling claim for communicable disease donor screening tests using cadaveric blood speciments from 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 2004

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36
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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37
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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38
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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39
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

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40
Material Type:
Book
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Guidance for industry : nucleic acid testing (NAT) to reduce the possible risk of parvovirus B19 transmission by plasma-derived 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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41
Material Type:
Book
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Guidance for industry : adequate and appropriate donor screening for hepatitis b : hepatitis b surface antigen (HBsAg) assays used to test donors of whole blood and blood components, including source plasma and source leukocytes.

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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42
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

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43
Material Type:
Book
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Guidance for industry : use of nucleic acid tests to reduce the risk of transmission of West Nile virus from donors of whole blood and blood components intended for transfusion and 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 2008

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44
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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45
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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46
Material Type:
Book
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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 adequately and appropriately reduce the risk of transmission of HIV-1 and HCV.

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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47
Material Type:
Book
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Guidance for industry : revised recommendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors.

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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48
Material Type:
Book
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Guidance for industry : certain human cells, tissues and cellular and tissue-based products (HCT/Ps) recovered from donors who were tested for communicable diseases using pooled speciments or diagnostic tests.

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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49
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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50
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

Online access

Results 1 - 50 of 305  for Bainbridge State College

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