A new Search Function for Guidances
Written by Garth Boehm January 06, 2015
A new Search function has appeared in the Guidances page of FDA's websiteurl. This search allows searching of guidances in several of FDA's so-called “program areas”. Now those of you who have had occasion to use FDA's general search function url will know that it is less than satisfactory. It often returns thousands of always irrelevant references. It seems that no matter how carefully you design your query, the results are useless, always it seems missing the most obvious documents.
Now lately in an excellent new feature FDA has been giving a list of other relevant guidances when new guidances are issued or revised. This is extremely helpful and I congratulate the Agency on this initiative. It saves countless repetitive hours of searching (manually if you want the correct answers) to be sure that you have located all relevant guidances. So this new automated guidance search function is greeted, at least by me, with great anticipation.
In order to try out this new function I chose to search for Guidances that are relevant to post approval changes for drugs (human drugs that is). This search is one of the most requested when people are thinking of making post approval changes and want to work out what is expected as supporting data. There are several relevant guidances that contribute to deciding on the support data and filing classification for post approval changes. These are:
These are followed by the so-called SUPAC guidances, SUPAC IR, SUPAC MR, SUPAC SS, and the Equipment Addendum. Then there is also the PAC ATLS for analytical laboratory changes and there may be a need for others.
In addition, this is a good search because FDA uses both post-approval and postapproval . I do not think they use post approval, but it could be used as a term. FDA's other search functions seem to be rigidly literal in interpreting search terms, that is a search for post-approval will not recognize postapproval or post approval.
Now you can get to this new search in at least 2 ways if your interest is human drugs, but I am sure there are other links within other program area parts of FDA's website. It turn out to be very important how you get to the search as we will see.
The first way is to go to FDA's Home Page, that is www.fda.gov. Near the bottom of this page on the left hand side is a box headed “Regulatory Information” and the first entry under this heading is “Guidance Documents”. Click this heading and a page appears with a short preamble followed by a search window titled “Search All Guidance Documents”. If you type in post approval changes you get 6 results, all guidances by title and all but one, somewhat surprisingly, relevant guidances for human drugs. These are the 3 SUPAC’s, the PAC-ALTS, and the Annual Report changes. However you do not get the most important guidance, the Changes guidance. Next I tried post-approval changes as my search term now using the hyphen. This made things worse, I only got 2 results, the SUPAC IR and SUPAC SS. Next I tried postapproval changes as the search term. That returned 4 results, SUPAC MR, PAC-ALTS, the Annual Reportable Changes and the irrelevant CVM BACPAC guidance (GFI #126).
So the good news is that it was pointing me to guidances and not text mentions in other documents. The bad news is that post approval, the term FDA does not use was most relevant but still missed the most important guidances, and post-approval and postapproval, the terms FDA does use faired significantly worse in pointing to relevant guidances. I do not understand the logic that leads to these strange results between these seemingly very similar search terms. Including quotes around the term made things worse as might be expected since this should force a literal for the term.
Overall these results were better than FDA's previous search but worse than using a Google search from outside of FDA's website. When exactly the same 3 search terms were used (without reference to FDA), the results returned were more relevant and included the “Changes” guidance in the first few results.
The results obtained as described above were obtained by searching from the link contained on the www.fda.gov home page and without specifying a program area, that is without specifying that it is the Drugs program that we are interested in. This is where things got rapidly worse. If you go to the search from www.fda.gov and click on Drugs under Browse Guidance Documents By Topic you are taken to the www.fda.gov/drugs version of the Guidance Page. This has a search box at the top which says (in greyed out type) Search the Drugs and Vaccines, Blood & Biologics Guidances Section. If you enter our search term post approval changes you get 383 results, almost all of which are from a text search of the three words separately. Also the title of the document is not included unless the text is in the title, however if you go through the first few pages it does return most of the relevant guidances including the “Changes” guidance. Search of post-approval changes returned 8830 results, again from a text search and again containing most of the relevant guidances within the results. Search of postapproval changes returned 2030 results with less of the relevant guidances up front. The problem with searching from this position is that the search is a text search and NOT a search of Guidance Documents which you do get from the entry point www.fda.gov.
The search function described works ONLY from the www.fda.gov entry point and only for a general search of all guidance documents. Attempts to narrow the search to say Drugs takes you to another page which does not have the same functionality.
The issue when searching for guidances is to be sure you have found all the relevant guidances. Unfortunately while this new search function does find many of the relevant guidances, and very importantly is a guidance document search and not a text search, it does not find them all. Conclusion, it helps but does not substitute for a complete search.
While I welcome and encourage the effort to improve FDA's website search capability, a little more beta testing would seem to be in order. A general Google search of post approval changes returns the 3 most important guidances as the first 3 results. Narrowing this Google search to the domain www.fda.gov produces all the relevant guidance documents (for drugs) within the first 20 search results.
