WHO To Clean Up Data Integrity Failings
Offers Streamlined Advice In A Revised Draft Guideline
The World Health Organization has proposed changes to its 2016 guideline on data integrity requirements to provide streamlined information to sponsors and to take account of experience gained to date.
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The World Health Organization has developed what it claims is the first comprehensive guidance document on data integrity that should help regulatory authorities and inspectors identify instances of pharmaceutical companies submitting insufficient or false data1.
While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.
The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.