Understanding the Scope of FDA Enforcement Authority and Actions

March 23, 2023 12:45pm

Jennifer L. Bragg
Skadden LLP
(Washington, DC)

  • 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