The OTC drug approval process

S. B. Fredd, R. Fisher, G. Friedman, R. McCallum, E. Schiff, W. Stern, D. Earnest, M. J. Kreek, S. Katz, J. H. Lewis

Research output: Contribution to journalComment/debatepeer-review

2 Scopus citations

Abstract

The OTC drug monography process and the NDA route of OTC drug approval are two different methods that reach the same results, the approval of safe and effective drugs. Both routes to OTC marketing require substantial evidence that the drugs are safe and effective for OTC use, including evidence that the drug would be safe for self-use without the supervision of a practioner.

Original languageEnglish (US)
Pages (from-to)12-14
Number of pages3
JournalAmerican Journal of Gastroenterology
Volume85
Issue number1
StatePublished - 1990
Externally publishedYes

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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