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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. 2010

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] 2001

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. 2016

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. 2006

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. 2007

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. 2001

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] 2006

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] 2006

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] 2001

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] 2001

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] 2005

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] 1999

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] 2001

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] 2006

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] 2004

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] 2004

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] 2002

Human subject research protections : hearing before the Subcommittee on Criminal Justice, Drug Polic

United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O. [Congressional Sales Office], 2001. 2001

The impact of randomized clinical trials on health policy and medical practice

Washington, D.C. : U.S. Congress, Office of Technology Assessment, [1983] 1983

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. 2002

Transforming clinical research in the United States challenges and opportunities : workshop summary

Washington, D.C. : National Academies Press, c2010. 2010