Access to Unapproved Drugs : FDA Policies on Compassionate Use and Emergency Use Authorization.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

United States. Food and Drug Administration.

United States.

Medical laws and legislation.

Risk assessment.

Physical Description:

1 online resource (1 online resource (21 pages)) : digital, PDF file

monochrome

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2015.

System Details:

System requirements: PDF reader software.

text file

PDF

Summary:

Reviews FDA policies on compassionate use and emergency use authorization of unapproved drugs. Examines underlying philosophy behind how FDA weighs risks and benefits when deciding whether to allow access to a medical product; addresses FDA policies on compassionate use and emergency use authority; and discusses obstacles to individuals expanded access to investigational drugs and possible remedies. Considers how expanded access to compassionate use and emergency use authority might form part of a broader approach to ensuring safe, effective, and available drugs.

Notes:

CRS Report.

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Sept. 2015). Reuse except for individual research requires license from ProQuest, LLC.

Other Format:

Microfiche version: Library of Congress. Congressional Research Service. Access to Unapproved Drugs

Access Restriction:

Restricted for use by site license.