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Drugs and Medicinal Products

Steptoe lawyers have in-depth knowledge of FDA’s regulatory framework related to human and animal drugs and medicinal products.  We assist both domestic and foreign drug manufacturers, importers, and distributors in all aspects of manufacturing, marketing and post-marketing safety issues.   Our extensive knowledge and experience in working with FDA enables us to proactively advise clients on the following regulatory issues:

  • Over-the-counter (OTC) drug monograph issue
  • Time and extent applications for OTC drugs and medicinal products
  • Drug and medicinal product labeling
  • Establishment registration and listing requirements
  •  Importation and exportation of drugs and drug components
  • FDA inspections and warning letters
  • FDA enforcement actions, including product seizures
  • Product recalls
  • Adverse event reporting
  • Current Good Manufacturing Practices (cGMP)
  • Drug and medicinal product master files