Drug Law: Understanding the Essentials of FDA's Authority over Innovative and Generic Pharmaceuticals 2013

Key Topics

• Key differences between the full new drug application (NDA), the 505(b)(2) NDA, and the abbreviated NDA (ANDA) applicable to generic drugs
• The basics of the FDA statutes and regulations governing the entry into the marketplace of prescription and over the counter drugs
• The Orphan Drug Act—incentives for treatments for rare diseases
• The route to the OTC market: Rx to OTC Switches vs. the OTC Monograph System
• Understanding the FDA’s enforcement authority, both administrative and judicial
• FDA regulation of drug promotion and advertising
• Pharmacovigilance requirements, including adverse event reporting
• The basics of drug good manufacturing practices (GMP) and quality requirements
• General controls, such as registration and listing
• The investigational new drug process and clinical trials

Who should Attend

• Senior drug company management
• Middle management and operations personnel from the following departments: Regulatory, Legal, Quality, Compliance, Marketing, Sales, Operations, Manufacturing, Medical Affairs, R&D