"Nota Bene" means "note this well" or "take particular notice." We at the O'Quinn Law Library will be posting tips on legal research techniques and resources, developments in the world of legal information, happenings at the Law Library, and legal news reports that deserve your particular attention. We look forward to sharing our thoughts and findings and to hearing from you.

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-Spencer L. Simons, former Director, O'Quinn Law Library and Associate Professor of Law



Wednesday, August 12, 2015

Searching and Using FDA Guidance Documents

When practicing in areas heavily regulated by government agencies, guidance documents can be invaluable resources. Generally, guidance documents describe the agency's interpretation of or policy on a regulatory issue. While these documents are often available through the agency’s website(s), they are often scattered throughout site and not always kept up to date. The larger the agency, the more difficult it can be to make sure you have performed a comprehensive search. For example, it is easy to find the EPA’s list of significant guidance documents, but there is no tool to perform comprehensive searches of all the agency’s guidance documents. 

The Food and Drug Administration is another large agency that produces a large number of guidance documents addressing a wide range of topics. The FDA’s guidance documents include documents relating to (1) the design, production, labeling, promotion, manufacturing, and testing of regulated products, (2) the processing, content, and evaluation or approval of submissions, and (3) inspection and enforcement policies.


Recently, the Food and Drug administration unveiled its new guidance document database containing many guidance documents issued by all of FDA's various offices and centers, and it is updated to clearly list all of the agency's most recent documents. The database allows the user to filter results by product type, FDA organization, type of document, subject, and whether the document is a preliminary draft or has been made final.  Users can also choose to browse the guidance documents by subject matter rather than performing a search. The ability to keyword searches in conjunction with useful filters makes researching FDA documents significantly more efficient. Hopefully, other agencies will follow the FDA's lead and advanced databases will become the norm across agency websites, rather than the exception.   

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