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The adequacy of FDA to assure the safety of the nation's drug supply hearing before the Subcommittee

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2007. 2007

Drug user fees : enhancing patient access and drug safety : hearing of the Committee on Health, Educ

United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008. 2008

Ensuring drug safety : where do we go from here? : hearing before the Committee on Health, Education

United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2005. 2005

Evaluating the effectiveness of the Food and Drug Administration Modernization Act : hearing before

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O. [Congressional Sales Office], 2001. 2001

FDA drug approval review time has decreased in recent years : report to congressional requesters.

United States. General Accounting Office.
Washington, D.C. (441 G St., NW, Rm. LM, Washington 20548) : U.S. General Accounting Office, [1995] 1995

FDA's drug approval process : up to the challenge? : hearing of the Committee on Health, Education,

United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2005. 2005

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

FDA's role in the evaluation of Avandia's safety : hearing before the Committee on Oversight and Gov

United States. Congress. House. Committee on Oversight and Government Reform.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008. 2008

The Food and Drug Administration's critical mission and challenges for the future : hearing before t

United States. Congress. House. Committee on Oversight and Government Reform.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2007. 2007

The Food and Drug Administration's generic drug review process.

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, 2008. 2008

From test tube to patient improving health through human drugs

[Rockville, MD] : U.S. Food and Drug Administration, Center for Drug Evaluation and Research, [1999] 1999

Guidance for industry and review staff nonclinical safety evaluation of reformulated drug products a

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

Guidance for industry nonclinical safety evaluation of drug or biologic combinations.

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

Guidance for industry nonclinical safety evaluation of pediatric drug products.

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

Guidance for industry photosafety testing.

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

Guidance for industry preparation of IDEs and INDs for products intended to repair or replace knee c

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] 2007

Guidance for industry providing regulatory submissions to CBER in electronic format, investigational

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

Guideline for the format and content of the nonclinical pharmacology/toxicology section of an applic

Rockville, Md. : Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, [1987] 1987

Prescription drugs many factors affected FDA's approval of selected "pipeline" drugs : report to con

United States. General Accounting Office.
[Washington, D.C.] : U.S. General Accounting Office, [2000] 2000

Risk and responsibility : the roles of FDA and pharmaceutical companies in ensuring the safety of ap

United States. Congress. House. Committee on Government Reform.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2005. 2005