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Investigative New Drug Application

Authors
Publisher
Elsevier Inc.
Identifiers
DOI: 10.1016/b978-0-12-386454-3.00862-9
Keywords
  • Fd&C Act
  • Us

Abstract

Abstract The 1962 Drug Amendment to the Food, Drug and Cosmetic Act (with subsequent amendments) contains the regulations specifically applicable to human drugs. There is a long and involved process for bringing a new drug to market, and these regulations are the roadmap to that end. This article is an overview of the process as a whole, and provides some idea of its depth.

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