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FDA Compliance
& Counseling

Overview

What We Do

  • Analysis of Hatch-Waxman Act and relevant regulations
  • Requirements for products with complex bioequivalence profiles (e.g., partial AUC, gastrointestinally targeted, narrow therapeutic index)
  • Requirements for generic sameness
  • Complex exclusivity issues
  • Draft Citizen Petitions and comments
  • Risk Evaluation and Mitigation Strategies (REMS)
  • Analysis of Biosimilar Price Competition and Innovation Act requirements
  • Orphan Drug Act
  • Regulatory support for patent and antitrust litigation