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.

“It is an honor to join this group of proven regulatory leaders with demonstrated dedications and success. I owe RAPS tremendous thanks for providing many wonderful educational and networking programs over my 30+ year career. The success I have enjoyed since founding Pathmaker FDA Law in 2017 would not have been possible without the ongoing support of this organization. I will continue to pass along to my clients and students the knowledge and value I have received from RAPS.”


Amy Fowler, RAC, FRAPS, Esquire

Meet Our Founder.

Amy Fowler is the President and Founder of Pathmaker FDA Law. She counsels clients and provides leadership in the development of domestic and international regulatory strategies and submissions.

For the past seven years she has led a team of experts in serving almost 100 Pathmaker clients. Her career in regulatory affairs roles spans more than 30 years and covers devices, pharmaceuticals and tissue products. She has experience working in large multinational corporations and also boutique consulting/law firms.

She has been an adjunct graduate studies professor for several years, teaching a variety of regulatory courses. She continues to enjoy the challenges of helping today’s innovators and entrepreneurs with the challenges brought by global regulators.