Well, for us old folks, change is always something that makes us queasy.  The newly-designed FDA website stirred those feeling all over again as we try to navigate the new links and find the information that was once at our fingertips (or at least in our bookmarks).  There were some wrong turns and some dead links along the way, while other links took us to seemingly yet unfinished reports or incomplete databases.

For instance, the FDA Web View published a story today about the new FDA website design and the link they listed (which was obviously obtained from the FDA site) failed to work.  I tried to find the product-specific bioequivalence guidance documents yesterday but kept winding up at a 4-page guidance document on how product-specific BE guidances were issued.  I tried again this morning and finally found it.  The new product-specific product guidance page was revised to provide a neat new search system that allows the user to search on different elements.  It also has a link to all newly added guidances and revised guidances since February 2018.  However, when you search on all the counts of newly added and revised guidances, the totals were 153 and 39, respectively.  I immediately went back to various blog posts I have compiled since February 2018 and found close to 200 revised guidances (one month had 52 alone) and I did not blog each time the BE guidance website was updated with additions or revisions.  So, something is wrong here.  I will say that there is a note on the web page (here) citing some discrepancies about filenames not matching the corresponding guidance titles, but it appears to go beyond that.

Surely, when a new website design is undertaken, it is difficult to see all of the problems until the new site goes live and then there is always a clean-up period.  So, we will have to see how that goes, but, until that time, we need to be somewhat wary of what it is we are seeing.   I did receive a response this morning from the FDA on the dead link I reported and here is what they said

“As you are already aware, FDA just launched a newly redesigned public website where we made improvements to provide a more modern and customer-centric web experience. Regrettably, some of the URL links did not migrate properly.  Therefore, we greatly appreciate your patience as we strive to correct the broken links.”

And for us old folks, we need to find the north star and try to navigate from that and hope we can find the right home port!  Good luck in your searches and please share your complaints or frustrations with me (r.pollock@LachmanConsultants.com) and I will pass them on to FDA!