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) |
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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