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FDA's Regulation of OTC Drug Products: 2-day In-Person Seminar

13 - 14 February 2014, Houston, United States


Introduction
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.

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Venue
Houston, TX (Venue to be announced shortly)

Houston, TX (Venue to be announced shortly), Houston, United States

Organised by
ComplianceOnline
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