FDA GMP Penalties Still Include Disgorgement, Agency Official Says
Executive Summary
FDA continues to believe it has the authority to pursue disgorgement of profits in its enforcement actions, FDA Deputy Associate General Counsel Eric Blumberg said
You may also be interested in...
FDA Can Seek Disgorgement As A Remedy Under FD&C Act, Court Rules
FDA's use of the remedy of disgorgement is permitted under the Food Drug & Cosmetic Act "in appropriate cases," according to a recent court ruling by the U.S. Circuit Court of Appeals in Denver
FDA Can Seek Disgorgement As A Remedy Under FD&C Act, Court Rules
FDA's use of the remedy of disgorgement is permitted under the Food Drug & Cosmetic Act "in appropriate cases," according to a recent court ruling by the U.S. Circuit Court of Appeals in Denver
GSK Consent Decree Sets “Aggressive” 150-Day Timeline For GMP Conformity
GlaxoSmithKline's consent decree mandates that the company notify the agency within 150 days of the corrective measures it has taken or plans to take in addressing FDA's good manufacturing practice concerns