Dear all,
I have a question regarding pick-up copy from previously approved efiles.
I am aware that all picked up copy needs to be highlighted in light yellow and the efile the copy has been copied from needs to be indicated.
Here are my questions:
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Can minimal changes (e.g. change to British English from American English, addition of a hyphen, change from semi-colon to colon or also correction of typos) be made to the copy without it losing its pick-up status? If so, do these changes need to highlighted in any particular way and does PAAB need to be made aware of them in the submission letter?
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As an example, I want to pick up the high level FB of a previously approved efile. The new ASP, however, only discusses one of the indications of the drug, whereas the previously approved efile includes multiple indications. Can I delete the paragraph that mentions the other indications if the remaining copy stays identical and would it then still count as pick-up?
I look forward to your reply. Thank you very much in advance.