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.

Awards

Chambers USA 2023

Health Law Practice recognized Nationally and in Boston and Washington, DC

Legal 500 United States

Practice recommended in Health Care: Life Sciences, Health Care: Service Providers

BTI Industry Power Rankings

Recognized as a “Leading Core Firm” in the health care industry

U.S. News and Best Lawyers®

Nationally ranked Tier 1 for Health Care

Modern Healthcare 2023

Modern Healthcare Top Healthcare Law Firms 2023 Data Dive by the numbers.

Our Experience

Communication Key in Client's Response to FDA

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.

FDA Team Advises Innovative Drug Company in Phase II

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.

FDA Team Helps Novel Therapeutic Developer Obtain Orphan Drug Designation

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

"At Mintz we have found partners, who aren't just 'another consultant.' They have proved to be supportive in sensitive topics, and have provided management with very practical support and guidance. It's good to have the access to people that have a unique combination of both legal and business attitude."

Itay BarneaOrthoSpace

"The FDA Practice at Mintz successfully designed and executed an appeal strategy for us that directly enabled our ability to commercialize our product. Their sense of timing and exceptional understanding of our medical device technology and submission strategy were key to an effective appeal rationale and outcome."