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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

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 industry content and format of investigational new drug applications (INDs) for phase 1

[Rockville, MD] : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1995] 1995

Guidance for industry drug-induced liver injury, premarketing clinical evaluation.

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] 2009

Guidance for industry E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic pote

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] 2008

Guidance for industry providing regulatory submissions in electronic format, receipt date.

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, [2007] 2007

Guidance for industry Q1B photostability testing of new drug substances and products.

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, [1996] 1996