Understanding the Scope of FDA Enforcement Authority and Actions
Bryant M. Godfrey
Partner
Foley Hoag LLP
- Enforcement overview—identifying the players and their positions
- Investigations, enforcement, litigation, and defenses
- Understanding potential punishments, including civil seizure, injunction, civil money penalties, and criminal prosecutions
- Exploring FDA compliance and enforcement mechanisms
- Inspections
- For cause inspections vs. routine inspections
- Communication with the FDA during inspections
- EIRs
- Form FDA 483 observations
- Untitled and Warning Letters
- Related to inspections
- Resulting from non-inspection data or information
- Examining enforcement actions related to digital advertising and social media