Bioequivalence and Bioavailability Forum

Dear all,

since mid-2008 FDA is redesigning their website.
Unfortunatelly starting with June 2009 most links to guidelines are broken without automatic redirect to new URIs (even FDA’s search-page sometimes leads to a nonexisting resource).
Sizes of many files are wrong by a mile (e.g., Bioresearch Monitoring/Compliance Program/Clinical Investigators: 240KB instead of 3.24MB).
Let’s have a look at one example: Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP. Validation failed with 175 XHTML-errors / 11 warnings and just [sic!] six CSS-errors. Although Dublin Core metadata are given in the header – only with double content and empty fields:

<meta name="dc.title" content= "Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP"/>
<meta name="dc.type" content="WebContent"/>
<meta name="dc.description" content="Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP"/>
<meta name="dc.language" content="en"/>
<meta name="posted" content="5/6/09 11:24 AM"/>
<meta name="keywords" content="Comparison Chart of FDA,EPA Good Laboratory Practice,GLP, Regulations,the OECD Principles of GLP"/>
<meta name="description" content="Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP"/>
<meta name="dc.publisher" content=""/>
<meta name="dc.audience" content=""/>
<meta name="dc.creator" content=""/>
<meta name="old_url" content=""/>
<meta name="dc.subject" content=""/>

I guess there are some fishbrains at work across the pond. If you only know the ‘old’ name of a file (e.g., from a link on the web) – and have no idea about keywords indexed in FDA’s document database – chances of finding the file are practically zero.
‘Pr_ofess^ionals’ at work! Too bad I can’t issue a ‘483’…

All guidance were not only moved to new locations, but also given a new file-names (generally of the type ucmXXXXXX.pdf or UCMXXXXXX.pdf, where XXXXXX is a six-digit number). In the ‘old’ system it was clear whether the document is a draft (XXXXdft.pdf) or a final version (XXXXfnl.pdf) – such information is lost in the new system. Internal links given in documents were not updated and lead to FDA’s 404 error page. HTML-versions of most documents were removed.

Example:

ANDA CHECKLIST FOR CTD or eCTD FORMAT
FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION
FOR FILING

old:
http://www.fda.gov/cder/ogd/anda_checklist.pdf
new:
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM151259.pdf

I updated the Guideline-collection accordingly. Here is a collection of some documents (in case you know just the old filename).