How to negotiate with the FDA

“With good tools you can achieve the best possible outcomes with FDA.”

Good negotiations are about understanding perspectives, having empathy, conducting yourself ethically, and gaining trust, says Nancy Isaac, BS, MPH, JD, a senior management leader and adviser in dynamic field of regulatory, quality, and clinical product development.

With more than 25 years in the regulatory environment, Isaac understands the strategic approach to obtaining approvals for medical devices, in vitro diagnostics, drugs, and biologics.

“The FDA is made up of hard-working, smart people just like you,” she says. “You can build effective relationships and build your credibility with FDA staff by preparing yourself for the rigorous challenges that lie ahead.”

Three Tips for Interacting with the FDA

isaac-nancy-3-ed-cropped — Nancy Isaac, BS, M.P.H., J.D., regulatory counsel and vice president of Quality Assurance at Moximed, is an instructor with the Regulatory Affairs certificate program at UCSC Silicon Valley Extension.

Isaac has recently redesigned the UCSC Silicon Valley Extension Interacting with the FDA course to incorporate new research in effective negotiation. In addition to teaching, Isaac serves on the UCSC Silicon Valley Extension advisory boards of the Regulatory Affairs and Medical Device certificate programs.

She offers up three tips for interacting with the FDA:

Be a clear and effective communicator. Know how to write and speak clearly and concisely.
Know how to analyze and synthesize information.
Be prepared. Know your “stuff” and know the rules of the game.

The Craft of Storytelling

“Everything is about framing,” Isaac says. “In this course, we will practice how to present data and critical information—the good, the bad, and the ugly—as well as how to put a context around it to shape a winning story.”

Negotiation as a Life Skill

Successful interactions with the FDA are no different from other successful interactions in your life, Isaac says.

Students will study nine key negotiation principles from ex-FBI hostage negotiator Chris Voss’ Wallstreet Journal’s bestseller book Never Spilt the Difference: Negotiating as if Your Life Depended Upon It.

Everything in life is a negotiation and hearing “no” is not the end of a conversation. According to Voss, it’s just the beginning.

In the complex world of regulatory affairs and medical device development, understanding effective communication makes an enormous difference.

“With good tools you can achieve the best possible outcomes with FDA,” Isaac says.