William H. Kitchens

Senior Counsel
171 17th Street NW
Suite 2100
Atlanta, Georgia 30363
404.873.8644 phone
404.873.8645fax

Representative Experience

  • Advised start-up company in the area of hair restoration research regarding most advantageous regulatory pathway for development and marketing of biological-device combination product.
  • Advised both sponsors and principal investigators of human clinical trials regarding compliance issues and related responses to the FDA.
  • Assisted a Georgia-based pharmaceutical company with preparation of FDA submissions and adverse events reports.
  • Served as lead counsel for a pharmaceutical company in connection with responses to FDA inspectional observations, warning letters, and FDA investigations, and the defense of seizure, injunctions and criminal actions in federal court.
  • Advised a pharmaceutical company regarding labeling and advertising activities for drug products.
  • Advised an eye care manufacturer regarding labeling and advertising activities for device products.
  • Served as lead counsel for an eye care manufacturer in connection with responses to FDA inspectional observations.
  • Advised multinational manufacturer of human biological and device products regarding approval strategies, advertising and promotional activities, and compliance issues.
  • Advised a biomedical company regarding labeling and advertising activities for multiple product lines.
  • Served as lead counsel for a biomedical company in connection with responses to FDA inspectional observations, warning letters, and FDA investigations, and the defense of seizure, injunctions and criminal actions in federal court.
  • Assisted a Georgia-based biologics and device company with preparation of FDA submissions, including 510(k) premarket notifications, new drug applications (NDAs), medical device premarket applications (PMAs), biological license applications (BLAs) and adverse events reports.
  • Advised a research pharmaceutical company regarding compliance issues and related responses to the FDA.
  • Assisted a Georgia-based long-term care facility with preparation of DEA submissions for pharmacy operation.
  • Advised a urological physician regarding compliance issues and related responses to the FDA.
  • Assisted a New Jersey-based pharmaceutical company with preparation of FDA submissions, including 510(k) premarket notifications, new drug applications (NDAs), medical device premarket applications (PMAs), biological license applications (BLAs) and adverse events reports.
  • Advised a major food service distributor regarding USDA food safety investigations at multiple facilities.
  • Serving as general counsel to the National Frozen & Refrigerated Foods Association.
  • Served as lead counsel for a nonprofit healthcare system in connection with responses to FDA inspectional observations concerning clinical trials.
  • Assisted a Georgia-based medical devices manufacturer with preparation of FDA submissions, including 510(k) premarket notifications and medical device premarket applications (PMAs).
  • Defended a California-based non-dairy food manufacturer in FTC investigation concerning substantiation support for advertising claim promoting cardiovascular health and wellness.
  • Advised numerous medical device manufacturers concerning product recalls and market withdrawals to minimize business disruption, cost and damage to brand.
  • Served as lead counsel for a medical device manufacturer in connection with responses to FDA inspectional observations and warning letters
  • Advised a leading supplier to the food service industry and manufacturer of non-dairy frozen foods concerning product recalls and market withdrawals to minimize business disruption, cost and damage to brand.
  • Advised a leading manufacturer of frozen baked foods regarding labeling and advertising activities, and in advertising substantiation by the FTC.
  • Served as lead counsel for a provider of frozen specialty seafood in connection with responses to FDA inspectional observations, warning letters, and FDA investigations, and the defense of seizure, injunctions and criminal action in federal court.
  • Served as lead counsel for an officer of a drug distribution firm in connection with DEA investigation and the defense of criminal action in federal court.
  • Coordinated regulatory due diligence for New-York based private equity firm evaluating acquisition of major medical devices company.
  • Advised hedge fund clients concerning FDA regulatory actions affecting their investment in pharmaceutical company.