How to Communicate Effectively With FDA

Posted 01 March 2009 | By Anthony CelesteCharles Celeste

While many businesses are reluctant to communicate with regulatory agencies for a variety of reasons, our experience suggests that these companies are also the ones most likely to have problems with the US Food and Drug Administration (FDA). For example, in the area of enforcement, failing to respond as quickly as possible to a Warning Letter or to Inspectional Observations (FD-483) can result in FDA taking regulatory action or other administrative follow-up action against a firm or its products without the benefit of any discussion between the firm and the agency. Obviously, there are times when it is necessary to communicate with FDA. Such instances include responding to FDA questions or deficiencies on pending applications. But, it is also important to communicate with FDA whenever the agency provides the opportunity, for example when a proposed regulation or guideline is published for comment. In these situations, input from the outside is critical to FDA finalizing its position and addressing concerns through the notice and comment system. Communicating effectively and in a timely manner with FDA can help your organization to achieve its goals and to maintain your good reputation with agency officials.

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