FDA Regulation of Follow-On Biologics

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Abstract:

Congress has been considering legislation that would expand regulatory activities of the Food and Drug Administration FDA by opening a pathway for the approval of follow-on biologics. A biologic is a preparation, such as a drug or a vaccine, that is made from living organisms. A follow-on biologic is similar to the brand-name innovator product made by the pharmaceutical or biotechnology industry. In contrast to a biologic, most commonly used drugs are synthesized via a chemical process.

Author(s):
Johnson, Judith A.
Author Organization(s):
LIBRARY OF CONGRESS WASHINGTON DC CONGRESSIONAL RESEARCH SERVICE
Descriptive Note:
Congressional rept.
Supplementary Note:
CRS Report for Congress
Pagination:
0017

Security Markings

DOCUMENT & CONTEXTUAL SUMMARY

Distribution:
Approved For Public Release
Distribution Statement:
Approved For Public Release; Distribution Is Unlimited.

RECORD

Collection: TR
Identifying Numbers
Report Number(s):
CRS-RL34045
Monitor Series:
CRS/DC
 Subject Terms
Joint Capability Areas:
JCA_1.4_Force Support; JCA_1.4.1_Force Health Protection; JCA_6.4.1_Secure Information Exchange; JCA_6_Net Centric; JCA_4.5.4_Requirements Definition; JCA_4.5_Operational Contract Support; JCA_6.4_Information Assurance; JCA_1.2.5_Lessons Learned; JCA_6.1.3_Switching and Routing; JCA_8_Building Partnerships; JCA_3.2_Engagement; JCA_3_Force Application; JCA_5_Command and Control; JCA_6.1_Information Transport; JCA_8.1_Communicate
Modernization Areas:
Biotechnology
Communities of Interest:
No COI(s) Identified
Descriptor(s):
*CLINICAL MEDICINE, *REGULATIONS, VACCINES, LEGISLATION, CHEMICAL REACTIONS, CONGRESS, DRUGS
Field(s)/Group(s):
Government and Political Science, Medicine and Medical Research
Keyword(s):
*BIOLOGICS, FDA(FOOD AND DRUG ADMINISTRATION)
Report Date:
2009 Feb 24
Creation Date:
2009 Apr 22