Pick-up copy from approved efiles
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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.
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-
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:
-
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?
-
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.
Hey @sabrinab
- Minimal changes such as those mentioned, would not void “direct pick-up”. We’d ask that you identify in the submission letter and highlight (versus shade) the specific instances. This can appear overtop of the shading.
- In this example it would not be considered direct pick-up. For efficiency sake, we’d ask that you identify the previously approved file, the content removed, and for extra support, providing the rationale can help.
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