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Subjects (1-25 of 25)
Clinical trials -- Government policy -- United States.
1
2010
E-REPORT
Challenges to FDA's ability to monitor and inspect foreign clinical trials.
United States. Department of Health and Human Services. Office of Inspector General, author.
[Washington, D.C.] : Department of Health and Human Services, Office of Inspector General, 2010.

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
2
1996?
BOOK

Copies / Volumes

LOCATION CALL # STATUS
 GovDocs Federal  HE 20.4002:H 88    AVAILABLE
3
2001
E-REPORT
Ethical and policy issues in international research clinical trials in developing countries.
United States. National Bioethics Advisory Commission.
Bethesda, Md. (6705 Rockledge Dr., Ste. 700, Bethesda 20892-7979) : National Bioethics Advisory Commission, [2001]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
4
2016
E-REPORT
FDA is issuing more postmarketing requirements, but challenges with oversight persist.
United States. Department of Health and Human Services. Office of Inspector General, author.
[Washington, D.C.] : Department of Health and Human Services, Office of Inspector General, 2016.

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
5
2006
E-REPORT
FDA's monitoring of postmarketing study commitments.
United States. Department of Health and Human Services. Office of Inspector General, author.
[Washington, D.C.] : Department of Health and Human Services, Office of Inspector General, 2006.

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
6
2007
E-REPORT
The Food and Drug Administration's oversight of clinical trials.
United States. Department of Health and Human Services. Office of Inspector General, author.
[Washington, D.C.] : Department of Health and Human Services, Office of Inspector General, 2007.

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
7
2001
E-REPORT
The Globalization of clinical trials : a growing challenge in protecting human subjects.
United States. Department of Health and Human Services. Office of Inspector General, author.
[Washington, D.C.] : Department of Health and Human Services, Office of Inspector General, 2001.

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
8
2006
E-REPORT
Guidance for clinical investigators, institutional review boards, and sponsors process for handling
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, [2006]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
9
2006
E-REPORT
Guidance for clinical trial sponsors establishment and operation of clinical trial data monitoring c
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health, [2006]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
10
2001
E-REPORT
Guidance for clinical trial sponsors on the establishment and operation of clinical trial data monit
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health, [2001]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
11
2001
E-REPORT
Guidance for industry acceptance of foreign clinical studies.
[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 : Center for Devices and Radiological Health, [2001]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
12
2005
E-REPORT
Guidance for industry collection of race and ethnicity data in clinical trials.
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 : Center for Devices and Radiological Health : Office of the Commissioner, [2005]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
13
1999
E-REPORT
Guidance for industry computerized systems used in clinical trials.
[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Nutrition : Center for Veterinary Medicine : Office of Regulatory Affairs, [1999]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
14
2001
E-REPORT
Guidance for industry E 10 choice of control group and related issues in clinical trials.
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, [2001]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
15
2006
E-REPORT
Guidance for industry gene therapy clinical trials, observing subjects for delayed adverse events.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2006]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
16
2004
E-REPORT
Guidance for industry IND exemptions for studies of lawfully marketed drug or biological products fo
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
17
2004
E-REPORT
Guidance for industry independent consultants for biotechnology clinical trial protocols.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research, [2004]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
18
2002
E-REPORT
Guidance for industry information program on clinical trials for serious or life-threatening disease
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2002]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
19
2009
E-REPORT
Guidance for industry postmarketing studies and clinical trials, implementation of section 505(o) of
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]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
20
2000
E-REPORT
Guidance for industry submitting and reviewing complete responses to clinical holds.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2000]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
21
1988
E-REPORT
Guideline for the monitoring of clinical investigations
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, [1988]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
22
2002
BOOK
Protecting human subjects in research : are current safeguards adequate? : hearing before the Subco
United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Public Health.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O. [Congressional Sales Office], 2002.

Copies / Volumes

LOCATION CALL # STATUS
 GovDocs Federal  Y 4.L 11/4:S.HRG.107-424    AVAILABLE
23
1994
BOOK
Protecting human subjects of research.
[Bethesda, Md. : Office of Communications, National Institutes of Health, 1994]

Copies / Volumes

LOCATION CALL # STATUS
 GovDocs Federal  HE 20.3062:H 88    AVAILABLE
24
2017
E-REPORT
Right to try : hearing before the Committee on Homeland Security and Governmental Affairs, United St
United States. Congress. Senate. Committee on Homeland Security and Governmental Affairs, author.
Washington : U.S. Government Publishing Office, 2017.

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
25
2017
BOOK
Right to try : hearing before the Committee on Homeland Security and Governmental Affairs, United St
United States. Congress. Senate. Committee on Homeland Security and Governmental Affairs, author.
Washington : U.S. Government Publishing Office, 2017.

Copies / Volumes

LOCATION CALL # STATUS
 GovDocs Federal/Fiche  Y 4.G 74/9:S.HRG.114-661    AVAILABLE
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