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

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 journal › Comment/debate › peer-review

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 language	English (US)
Pages (from-to)	12-14
Number of pages	3
Journal	American Journal of Gastroenterology
Volume	85
Issue number	1
State	Published - 1990
Externally published	Yes

ASJC Scopus subject areas

Hepatology
Gastroenterology

Cite this

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title = "The OTC drug approval process",

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.",

author = "Fredd, {S. B.} and R. Fisher and G. Friedman and R. McCallum and E. Schiff and W. Stern and D. Earnest and Kreek, {M. J.} and S. Katz and Lewis, {J. H.}",

year = "1990",

language = "English (US)",

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AU - Fredd, S. B.

AU - Fisher, R.

AU - Friedman, G.

AU - McCallum, R.

AU - Schiff, E.

AU - Stern, W.

AU - Earnest, D.

AU - Kreek, M. J.

AU - Katz, S.

AU - Lewis, J. H.

PY - 1990

Y1 - 1990

N2 - 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.

AB - 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.

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M3 - Comment/debate

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The OTC drug approval process

Abstract

ASJC Scopus subject areas

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