Affordable Access

Publisher Website

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.

There are no comments yet on this publication. Be the first to share your thoughts.

Statistics

Seen <100 times
0 Comments

More articles like this

The investigative process for new drugs.

on Annals of allergy December 1989

Airway smooth muscle as a model for new investigat...

on Therapeutic advances in respir... June 2008

New drug applications.

on Science Jul 05, 1991
More articles like this..