Enforcement

KKB handles a wide range of drug-related enforcement activities by FDA, FTC, DEA and other federal and state regulatory agencies. These include:

  • FDA enforcement proceedings, including the conduct of inspections, responses to inspectional observations, Warning Letters, section 305 hearings, negotiation of consent decrees, litigation, and implementation of FDA's Application Integrity Policy (AIP)
  • FDA-related import and export issues
  • Assistance with recalls
  • FTC investigations of advertising claims
  • Self regulatory cases involving drug claims (before the National Advertising Division (NAD))

Kleinfeld, Kaplan and Becker, LLP

1140 Nineteenth St. N.W. Suite 900 / Washington, DC 20036 / P 202 223 5120 / F 202 223 5619

Sign up for updates