FDA Regulatory Status Call

FDA Regulatory Status Call

Managing Engagement with the US FDA to Avoid Penalties

One of the most challenging aspects of working with the FDA is engaging directly with the FDA. In particular when the topic of discussion is potential enforcement action, such as a Warning Letter or Recall. This is often the case for a FDA Regulatory Status Call. The Status Call may be conducted by the Center for Drug Evaluation and Research (CDER) to address concerns about an unapproved new drug, the Center for Food Safety and Applied Nutrition for the same purpose based on a dietary supplement or cosmetic that makes prohibited claims, or the Center for Devices and Radiological

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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.

1 Comment

  1. FDA Warning Letters - FDA Attorney on April 13, 2015 at 10:21 am

    […] For example, our firm routinely interacts and responds to the FDA both through Warning Letters, Regulatory Status Calls, Facility Inspections, and Form 483s. This experience can guide a recipient company through a […]

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