Also, in light of recent events concerning enforcement actions and recalls in the OTC industry, the conference will feature sessions on effective recall and remediation strategies, cGMPs, AER review protocols, and FDA, DOJ and FTC enforcement activities.
“The FDA’s proposed new paradigm for a third class of drug coupled with recent enforcement activity will change the OTC arena,” said Lisa J. Piccolo, Senior Industry Manager for Life Sciences and Health care at ACI. "We have designed this conference as a comprehensive forum where the latest legal and regulatory developments affecting non-prescription pharmaceutical products can be discussed. We are also delighted to give our delegates the opportunity to hear directly from the FDA and USP on the proposed new paradigm, potential changes to the OTC Review process, and enforcement.”
More information about this event, including a full agenda, faculty list, and brochure can be accessed at http://www.AmericanConference.com/