What is a guidance document and how should they be used? A guidance document represents the FDA’s current thinking on a topic. Per FDA’s website, guidance documents “do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternate approach if the approach satisfies the requirements of the applicable statues and regulations.” Guidance documents usually discuss FDA’s interpretation of their policy on a regulatory issue.
One way to think about guidance documents are as suggested opinions of best practices from the FDA. Guidance documents work hand-in-hand with the applicable regulations (21 CFR 812, 312, 50, 54, 56) to deliver recommendations of leading best practices to produce clinical research in the manner that protects patient’s rights, safety, and welfare while delivering clinical data with integrity. The phrase “can use an alternate approach” may seem confusing, but this allows for interpretation of the guidance document with respect to the conduct of clinical studies, as long as the requirements of the regulations are satisfied.
The FDA recently created a database for all guidance documents with the goal of creating a convenient way to search all FDA guidance documents from a single location. This database can be accessed through their publically available website. It allows for searching based on product, date issued, FDA organization, document type, subject, draft or final status, open for comment, and comment closing date for draft guidances. Also, a Regulatory Affairs Professional Society (RAPS) article stated that the database is configured to eventually include information from FDA’s operation manuals, compliance policy guides, import alerts, and more. Importantly, it was recently noted that the database includes many but not all guidance documents yet. Stay tuned for updates on this key resource.
How do you leverage guidance documents when conducting clinical research? Please feel free to share your comments below.