Bringing a product through the regulatory process requires knowing when to push back, when to go along, and when to change course.  Our attorneys have helped bring many FDA-regulated products through the process: drugs and biological products, medical devices, controlled substances, foods, food additives, food contact substances, over-the-counter drugs, and veterinary drugs and devices.

We assist clients with agency meetings, understanding the data required for marketing authorization of a product, and, when appropriate, appealing agency decisions.

HPM advises clients on premarket issues and approval strategies, including:

  • Requirements for Investigational Products (INDs and IDEs)
  • Clinical Studies and Clinical Holds
  • Marketing Authorizations for all FDA regulated products
    • Medical Device Premarket Notifications (510(k)s)
    • De Novo Petitions
    • Premarket Approval Applications (PMAs)
    • New Drug Applications (NDAs)
    • Biological License Applications (BLAs)
    • New Animal Drug Applications (NADAs)
    • Food Additive Petitions (FAPs)
    • Color Additive Petitions (CAPs), etc.)
  • 513(g) Requests
  • Meetings with FDA
  • Product Reclassification
  • Orphan Products (Orphan Drugs, Humanitarian Devices, Minor Use/Minor Species Drugs)
  • Product Approval Strategies
  • Preparation for FDA Advisory Committee / Advisory Panel meetings
Professionals