Drug Law: Understanding the Essentials of FDA`s Authority over Innovative and Generic Pharmaceuticals 2013 is a seminar that covers topics such as:
- 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
Drug Law: Understanding the Essentials of FDA`s Authority over Innovative and Generic Pharmaceuticals 2013 brings together:
- 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
