Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.

The Food and Drug Administration and the Consumer Product Safety Commission have regulations pertaining to OTC drugs. The U.S. Food and Drug Administration's (FDA) 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 OTC drug products into the U.S. Under this current regulatory regime, there are 4 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); (c) via the currently popular Rx-to-OTC Switch Process or (d) via an ANDA citing a previously-approved product.