US Food and Drug Administration (FDA) review summaries, previously referred to as summary basis of approval documents, can serve as invaluable sources of regulatory strategy information, the details of which are not publicly available from any other source. When the FDA announced its plans to use a more streamlined approach to communicating regulatory decisions through an integrated assessment process and review document, it raised concern among those who contribute to and...

This article focuses on regulatory intelligence communication approaches for medium to large companies and highlights the advantages and disadvantages of each. Introduction To stay current with the rapidly changing landscape, regulatory affairs professionals must monitor and identify pertinent regulatory information on a continual basis. This information must then be analyzed and interpreted for the application and implications to team projects, the organization and pot...

By Kimberly Belsky, Emily Huddle and Elizabeth Rosenkrands-Lange This article addresses the question whether to submit comments to health authorities regarding new regulatory documents or proposed changes to existing documents. The authors provide several considerations for making such decisions as well as ways of determining if the submitted comments have been "successful." Introduction When deciding whether it is useful or beneficial for a company to offer comments o...

This article discusses the impact of the Internet with regard to the amount and transparency of information offered by regulatory health agencies with an emphasis on the role of regulatory intelligence in monitoring the global environment and the subsequent communication obtained from this information. Introduction Welcome to a wider world. Over the past two decades, the Internet has led to an unprecedented volume of readily accessible and seemingly endless informatio...