FDA

Navigating the complex web of regulations and policies enforced by the US Food and Drug Administration (FDA) requires a strategic partner with practical, hands-on industry knowledge. Mintz Levin’s FDA attorneys have deep experience counseling companies at all stages of the product life cycle, from product development — including preclinical testing and clinical trials — through product approval and myriad post-marketing requirements relating to product launch, advertising and promotion, FDA inspections and enforcement actions. Our market insight allows us to anticipate changes to the business landscape and help our clients adapt while maximizing profitability. We also provide experienced counsel to companies, investment banks, venture capital firms, and private equity firms in connection with public and private stock offerings, mergers and acquisitions, and other transactions involving FDA-regulated companies.

We provide strategic life cycle counseling to companies in the following areas:

  • Medical devices
  • Mobile health and connected health apps, including privacy and data security matters
  • Regenerative medicine, cellular, and tissue products
  • In vitro diagnostics and precision medicine
  • Pharmaceuticals and biologics, including biosimilars
  • Compounding pharmacies and outsourcing facilities
  • Cosmetics and food

Our FDA advice and counsel does not happen in a vacuum. Mintz Levin’s FDA attorneys are strategically situated within the firm’s Health Law Practice because we understand that the most effective strategic plan for our clients is one that incorporates reimbursement and pricing models, allowing you to successfully enter and operate in the health care delivery system. This integrated approach means that our clients receive additional layers of regulatory and compliance counseling, including advice regarding the False Claims Act and federal Anti-Kickback Statute.

Areas of Focus

  • Regulatory strategy and approval pathways
  • Product development and clinical research
  • Advertising and promotion
  • Regulatory compliance, enforcement, and litigation
  • FDA interactions and disputes
  • Policy and legislation (through our affiliated lobbying team at ML Strategies)
  • Corporate transactions and commercial relationships
  • Drug quality and security matters, such as product traceability