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FDA Regulatory

Strategic Regulatory Counseling Throughout the Product Lifecycle

​Whether you're looking to bring a product to market — or faced with responding to an FDA warning letter — Mintz will serve as a hands-on partner. Our attorneys will guide you through the complex web of regulations and policies enforced by the FDA. We have the market insight to anticipate changes to the business landscape. So you can count on us to help you adapt while maximizing profitability.

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Our Experience

Case Study
Mintz is helping a client that manufactures medical technologies for facility and home-based care design and implement corrective actions in response to an FDA follow-up inspection. Although the client has two open FDA inspections, Mintz attorneys have helped the company avoid a warning letter.
Case Study
Mintz represents a company developing new drug therapies to treat neurodegenerative diseases and developmental disorders. Mintz advises the company on FDA issues, presentations to the company's board, and publication and presentation of the data.
Case Study
Mintz advised Glia, LLC on its successful bid to obtain orphan drug status from the FDA for its topical gel to treat ocular Graft-versus-Host Disease. The disease can affect stem cell or bone marrow transplant recipients and cause intense eye pain, ocular degeneration, and blindness.

Our Approach

Our FDA work doesn't happen in a vacuum. We know that as a company operating in the health care or life sciences industry, you need a holistic strategic plan. That’s why our FDA attorneys are situated within the firm’s Health Law Practice. While focusing on your FDA regulatory strategy, we can incorporate reimbursement and health care compliance — allowing you to launch a product and operate in the complicated health care delivery system. This integrated approach gives clients additional layers of regulatory and compliance counseling. Like advice regarding the federal False Claims Act, Anti-Kickback Statute, and privacy compliance. We have you covered from idea to patient.

Clients in Industry-Leading Areas
  • Medical devices
  • Food and dietary supplements
  • Regenerative medicine, cellular, and tissue products
  • In vitro diagnostics and precision medicine
  • Pharmaceuticals and biologics, including biosimilars
  • Compounding pharmacies and outsourcing facilities
  • Mobile health and digital therapeutics
  • Cosmetics
​Areas of Focus
  • Regulatory strategy and approval pathways
  • Product development and clinical research
  • FDA submissions and strategic communications
  • Enforcement, warning letters, and inspections
  • Policy and legislation (with ML Strategies)
  • Corporate transactions and commercial relationships
  • Drug quality and security matters, such as product traceability
  • Labeling, advertising, and promotion

What Our Clients Are Saying

Meet Mintz

Our attorneys collaborate with your team to help you meet regulatory challenges while advancing your business objectives.