Documents in the Internet Archive [Tips / Tricks]

posted by Helmut Homepage – Vienna, Austria, 2013-11-21 16:45  – Posting: # 11938
Views: 9,135

Dear all,

sometimes one needs a previous version of a document which is no more available on agency’s websites. Why don’t they have the version control / audit trail they require from us?

Example: A BE study on alendronate was performed in August 2008 according to FDA’s draft guidance (January 2008). Due to improvements in bioanalytical technology in the October 2011’s revision FDA requires plasma data instead of urine. The study was submitted to Oman’s authority which required a copy of the old guidance before accepting the study. Procedure:Problems:

Cheers,
Helmut Schütz
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