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.
Agenda Highlights
- Overview of the organizational structure of the 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
Statutes Covered
- Federal Food, Drug & Cosmetic Act (FD&C Act)
- Kefauver-Harris Amendments
- Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman)
- Biologics Control Act
- Food and Drug Administration Safety and Innovation Act (FDASIA)
- Food and Drug Administration Modernization Act (FDAMA)
- Food and Drug Administration Act (FDAAA)
- Biologics Price Competition and Innovation Act (BPCIA)
- Prescription Drug User Fee Act (PDUFA)
- Generic User Fee Amendments (GDUFA)
- Drug Quality and Security Act (DQSA)
- 21st Century Cures Act
Attendee Resources
These valuable takeaways will be provided onsite:
- A binder of speaker handouts and related reference materials
- Access to an electronic copy of the FDCA Statutory Supplement, 2021 2nd Edition
Who Should Attend
- New legal and regulatory professionals
- Seasoned practitioners new to the topic or wanting a refresher
