Nixon Peabody partner Hannah Bornstein will be speaking on "Understanding the Scope of FDA Enforcement Authority and Actions," at the FDA Boot Camp.
Details from the conference website
Session agenda points include:
- 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
For more information or to register, visit the conference website.