Drug safety : FDA faces challenges overseeing the foreign drug manufacturing supply chain : testimony before the Committee on Health, Education, Labor, and Pensions, U.S. Senate / statement of Marcia Crosse.

Format:

Book

Government document

Author/Creator:

Crosse, Marcia

Contributor:

United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions

United States. Government Accountability Office

Series:

Testimony ; GAO-11-936 T.

Testimony ; GAO-11-936T

Language:

English

Subjects (All):

United States. Food and Drug Administration--Rules and practice.

United States.

United States Food and Drug Administration.

United States. Food and Drug Administration.

Drugs--Safety measures.

Drugs.

Drugs--Safety measures--Government policy--United States.

Drug Approval--organization & administration.

Drug Approval--legislation & jurisprudence.

Medical Subjects:

United States Food and Drug Administration.

Drug Approval--organization & administration.

Drug Approval--legislation & jurisprudence.

United States.

Genre:

Rules

Physical Description:

1 online resource (15 pages).

Other Title:

FDA faces challenges overseeing the foreign drug manufacturing supply chain

Place of Publication:

[Washington, D.C.] : U.S. Govt. Accountability Office, [2011]

Summary:

Globalization has placed increasing demands on the Food and Drug Administration (FDA) in ensuring the safety and effectiveness of drugs marketed in the United States. The pharmaceutical industry has increasingly relied on global supply chains in which each manufacturing step may be outsourced to foreign establishments. As part of its efforts, FDA may conduct inspections of foreign drug manufacturing establishments, but there are concerns that the complexity of the drug manufacturing supply chain and the volume of imported drugs has created regulatory challenges for FDA. FDA has begun taking steps to address some of these concerns, such as the establishment of overseas offices. This statement discusses (1) FDA's inspection of foreign drug manufacturing establishments, (2) the information FDA has on these establishments, and (3) recent FDA initiatives to improve its oversight of the supply chain. The statement presents findings based primarily on GAO reports since 2008 related to FDA's oversight of the supply chain.

Notes:

Title from title screen (viewed on Nov. 29, 2011).

"For release on ... September 14, 2011."

Includes bibliographical references.

OCLC:

764534624