Posted 06 January 2015
By Alexander Gaffney, RAC
The holidays may be over, but the US Food and Drug Administration (FDA) has just given regulatory professionals around the world an unexpected gift: a unified, easy-to-view database of guidance documents issued by the agency.
Editor's note: A previous iteration of this story noted the database currently contains all guidance documents issued by the agency. That statement was premature. The database currently contains many--but not all--guidance documents. We regret the error.
The new database, unveiled in an email sent to regulatory professionals in the waning days of 2014, serves as a vast improvement over FDA's previously fragmented lists of guidance documents, which were scattered throughout the agency's website and not always kept up-to-date.
In contrast, the new guidance database contains many guidance documents issued by all of FDA's various offices and centers, and is updated to clearly list all of the agency's most recent documents as well.
The system also contains a number of useful features. For example, regulatory professionals can search for guidance documents by product type (e.g. biologics or medical devices) or by FDA office (e.g. CBER, CDER, CDRH), allowing the user to quickly find relevant documents.
In addition, the database contains a search bar that automatically populates results as the user types a query, making it much easier to find a document without resorting to a time-consuming series of searches.
The database also contains useful information such as links to the FDA docket related to a guidance, whether there is an open comment period on the guidance, whether the guidance is in draft or final form, when it was issued, and which FDA centers have signed on to the guidance.
The database also seems to be configured to eventually include information from FDA's operation manuals, compliance policy guides, import alerts and more.
Link to FDA's Guidance Database