Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
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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