U.S. OTC Drug Labeling Regulations & Requirements 2016

Topics

• Labeling rules promulgated under the Food, Drug & Cosmetic Act & the Fair Packaging& Labeling Act
• Background to FDA OTC Drug Regulations
• OTC Monographs and their importance to Drug Marketing and Labeling
• Different ways that OTC drugs can be marketed in the U.S
• Compliance with Drug Facts Labeling regulations
• FDA Requirements for OTC Drug Labels
• Adverse Event Reporting Label requirements for OTC Drugs

Who should Attend

• Quality managers
• Regulatory Affairs managers and Regulatory associates
• Drug Marketing managers
• Labeling managers