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

Contained In:

ProQuest U.S. Congressional Research Digital Collection

Place of Publication:

[United States] [publisher not identified] 2015

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

Vendor supplied data

Other Format:

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

Publisher Number:

CRS-2015-DSP-0359

Access Restriction:

Restricted for use by site license