FDA Regulation of Follow-On Biologics.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

Medical laws and legislation.

Physical Description:

1 online resource (19 pages, digital, PDF file)

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2008.

System Details:

text file

Summary:

Discusses proposal to create FDA pathway for approval of follow-on biologics, which are medical preparations made from living organisms. Provides introduction to relevant law, FDA regulatory framework, and scientific challenges for FDA in considering approval of follow-on biologics; and describes proposed legislation.

Notes:

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Dec. 2010). Reuse except for individual research requires license from ProQuest, LLC.

CRS Report.

Other Format:

Microfiche version: Library of Congress. Congressional Research Service. FDA Regulation of Follow-On Biologics

Access Restriction:

Restricted for use by site license.