FDA Regulation of Follow-On Biologics

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.

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Document Details

Document Type
Technical Report
Publication Date
Feb 24, 2009
Accession Number
ADA496344

Entities

People

  • Judith A. Johnson

Organizations

  • Library of Congress

Tags

DTIC Thesaurus Topics

  • Biological Factors
  • Biological Products
  • Blood
  • Chemistry
  • Congress
  • Dermatologic Agents
  • European Union
  • Health Care
  • Health Services
  • Hormones
  • Law
  • Medical Personnel
  • Protein Sequence Analysis
  • Public Health
  • Therapy
  • United States
  • Vaccines

Fields of Study

  • Medicine

Readers

  • Defense Technology Research and Development.
  • Gulf War Illness and Chronic Multisymptom Illness in Veterans.

Technology Areas

  • Biotechnology
  • Biotechnology - Cancer Biotech