Category: Regulatory

Top 10 problems encountered in IND or BLA submissions

24th October 2013

Category: Bioanalytical / Regulatory

Tags: , ,

By: Dr Daniel Galbraith, CSO,

During the Well Characterised Biological Congress an FDA reviewer gave us an insight into some of the common problems encountered in IND or BLA submissions with a list of the Top 10 inadequacies. Number 1 – The lack of procedural details contained within the submission. What was clear was that the FDA requires a working SOP More

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