FDA Regulations for Marketing OTC Drugs in the U.S. 2015

Topics

• Different Ways that OTC Drugs can be Marketed in the U.S. (NDA, Rx to OTC Switch vs. Monograph process)
• Background and History of OTC Drug regulations
• FDA Drug Facts Labelling Requirements
• Overview of the OTC Drug Monographs and Their Importance
• FDA Regulations for Required Adverse Event Reporting

Who should Attend

• QA Managers
• Regulatory Affairs Managers and Associates
• Anyone interested in learning about U. S. OTC Drug regulatory requirements and compliance
• OTC Drug Marketing Managers