The U.S. Food and Drug Administration's ("FDA鈥�) is responsible for the regulation and oversight of the U.S. OTC drug market. Congress has granted FDA regulatory authority over the formulation, manufacturing, labeling, marketing and promotion; and import / export of OCT drug products into the U.S. Under this current regulatory regime, there are 3 pathways that a company may follow to enter the OTC drug market including (a) following an appropriate Drug Monograph; (b) with an Agency approved New Drug Application ("NDA鈥�); or (c) via the currently popular Rx-to-OTC Switch Process.
FDA's Regulation of OTC Drug Products: 2-day In-Person Seminar
13 - 14 February 2014, Houston, United States
Introduction
Venue
Houston, TX (Venue to be announced shortly)
Houston, TX (Venue to be announced shortly), Houston, United States
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