Bioequivalence and Bioavailability Forum

Dear all,

although I’m trying to keep the Guidance Collection up to date (the last update is stated in the second paragraph, and the footer), I would give some alternatives:

• FDA-CDER
  The What’s New by Date page, where recent changes are kept for approximately 30 days. You also may opt for e-mail updates or an RSS-Feed. If you don’t have a feed-reader see the rendered version at our site.
  
  
• EU-EMEA
  You may receive e-mail alerts from EMEA for Human_Medicinal_Regulatory_Guidance; an archive is also available. Another option is EMEA’s ‘What’s New Page’ (including an archive).

A commercial service (the ‘Global Regulatory Activity Digest’) is run by the Drug Information Association (DIA).

Another private collection of guidelines is maintained by Ganesh M. Mugundu (webarchive).

Dear visitors,

as stated in the Guidance-Collection I will try to keep the collection up-to-date.
Documents published within the last two years are marked; additions within the last four months are accessible by direct links from the introductory section.

To quote:

If you encounter broken links or are acquainted with any missing / updated documents please notify the webmaster.

Recently I’m getting e-mails sent through the contact-form (which is open for anybody) with laconic content like:

‘Some guidelines missing!’

This doesn’t help. Please send me a direct link or at least the complete title of the document.

Dear all,

if you have questions regarding regulatory requirements, please consult the Guidelines / Guidances first.

Only if you cannot find an answer there (or a guideline is ambiguous in a particular topic) and the Forum’s Search did not give you an answer as well, start a new thread.

Thank you very much.

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).