Helping manufacturers and distributors get products to market.

Pathmaker FDA Law specializes in medical device and pharmaceutical regulatory law.

Navigate Regulatory Uncertainty

For nearly 30 years, the attorneys of Pathmaker FDA Law have led medical device, pharmaceutical, and other highly regulated business through regulatory uncertainty. By developing and executing visionary regulatory strategies, they have guided hundreds of medical devices and drugs to market.

Serving your Business Needs

Pathmaker FDA Law focuses only on businesses regulated by FDA or comparable international regulatory agencies.

The firm primarily serves medical device and pharmaceutical companies looking to get their products to market.

Know Your Goals and Challenges

We have experience working in the medical device industry before practicing law. We have personally experienced the challenges faced by the medical and pharmaceutical industries, and that experience sets Pathmaker FDA Law apart.

Amy Fowler, RAC, Esquire

Meet Our Founder.

Amy Fowler has almost 30 years of regulatory affairs experience in medical devices and pharmaceuticals, assisting over 100 companies through various aspects of FDA regulation.

Amy founded Pathmaker FDA Law in 2017 and has since led a team of attorneys and consultants, helping both large and small companies bring their medical devices and pharmaceuticals through the complicated process of FDA approval.

She has a bachelor’s degree in chemistry from the University of Minnesota and her Juris Doctor from Mitchell Hamline University School of Law.

Amy has also been Regulatory Affairs Certified by the Regulatory Affairs Professionals Society since 1995 and continues to share her passion for FDA law through a multitude of speaking engagements and mentorships for the next generation.