Explore the essentials of drug law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.
- Overview of the organizational structure of FDA
- FDA’s regulatory process for drugs
- New Drug Application Process (NDA)
- Biologics and biosimilars
- Post-approval drug safety issues
- Advertising and promotion requirements
- FDA’s enforcement tools and procedures