Tips for Appeals and FDA Meetings: Reflections from Recent Visit to FDA HQ

An enforcement meeting with the US FDA, whether in person or over the phone, can become an intimidating task. There are number of variables to balance: process, terms, regulations and statutes, and personalities. All of this on top of the administrative check-list that accompanies any interaction with a Governmental agency. I could think of no better time to re-visit the subject then fresh from a visit to the FDA’s White Oak Campus in Silver Spring MD (FDA HQ).

Administrative Process

If you are visiting the FDA’s headquarters in Silver Spring Maryland (just outside of Washington D.C.) there are a number of administrative steps to tend to. Before you arrive to the FDA campus an FDA employee will coordinate the time and building location. The FDA campus is extensive and verifying the building number will be important for your arrival. If you are visiting the FDA campus from anywhere outside the US be sure to plan far in advance the appropriate visitor form. Upon arriving to the FDA campus you will need to check-in with security, take a photo for your visitor pass, and wait for an escort to guide you to your meeting.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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