RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > How to Communicate Effectively With FDA

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.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe

Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.