Product Development & Authorization

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