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