Is FDA Secretly Reducing the Number of Its Guidance Documents?
[Thursday, November 8, 2018] A review of FDA’s webpage listing available Guidance Documents shows that in the last two years, the total number of available documents is steadily decreasing. This despite FDA having a full roster of new guidance documents being created and released. A screenshot in Oct 2017 showed 3164 active Guidance Documents on FDA’s website; a similar search on 8 Nov 2018, shows 2677, a drop of 15% in the total number of Guidance Documents. There is no way to accurately verify the number of Guidance Documents withdrawn by FDA as FDA generally does not publicize the withdrawal of every document from its website. It does announce major changes and maintains some older documents clearly marked “For Archival Reasons”, but over the last year such announcements have been minimal. Similar reduction in the number of guidance documents have been noticed by other observers though the scale of reduction varies probably based on the search practices followed. FDA’s Guidance Documents can be withdrawn for several reasons; a newer version may have been released making the older one obsolete, the document may represent a practice no longer followed; or multiple documents may have been consolidated to fewer documents. The withdrawal of Guidance documents of this large scale, if true, would be alarming as many users of these documents do not visit the FDA webpages regularly and rather use locally saved documents. Using an older Guidance Document may be of limited help if it does not reflect current thinking. Most Guidance Documents discuss basic concepts that should not change much over time, and many of the newer versions are mostly updated to add to the previous version. So, using an older version of a given document will not necessarily be disastrous but still using the current version is probably the smarter option. It is always best to check on FDA’s website and only use “current” Guidance Documents. With the apparently increased frequency of changes in Guidance Documents, it is almost a given that anyone not picking a current Guidance Document from FDA’s website, may not get the most relevant advice from FDA.
|
|