Product Approval

The firm has developed a reputation for its expertise in new drug development. Working with scientific and medical experts, we assist companies in preparing and filing full new drug applications (both 505(b)(1) and 505(b)(2) NDAs) and abbreviated new drug applications (ANDAs), biologic license applications (BLAs), including biosimilar BLAs, and investigational new drug (IND) applications. We advise on:

  • Statutory and regulatory standards
  • Approval strategies, from the investigational stage through options such as fast track breakthrough therapy, accelerated approval and treatment INDs
  • Application process, including meetings, internal appeals, user fee issues, advisory committee presentations, Drug Enforcement Administration (DEA) scheduling, and administrative proceedings
  • Agreements with clinical investigators, contract research organizations, and data management organizations
  • Post-approval support, including supplemental NDAs and agency actions based on new information
  • Rx-OTC switch applications
  • Risk Evaluation and Mitigation Strategies (REMS)
  • Hatch-Waxman lifecycle management strategies

Exclusivity

HPM has expertise in every aspect of FDA-related marketing protection requirements, including:

  • New drug and biologic exclusivity
  • ANDA exclusivity
  • Patent term extension
  • Orphan drug exclusivity
  • Pediatric use exclusivity
  • Citizen petitions

Compliance and Post-Marketing Requirements

HPM has broad experience in issues relating to FDA regulation of marketed drug products, including:

  • Establishment Registration and Product Listing
  • Adverse Drug Reports
  • Labeling Changes
  • Supplemental Applications
  • Applications Integrity Policy
  • Bioresearch Monitoring
  • Prescription Drug Marketing Act, Drug Supply Chain Security Act/Drug Sampling/Wholesaler Requirements
  • Good Manufacturing Practice (GMP) Compliance
  • Drug Master Files
  • Compounding
Professionals
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