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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 729 - Can you please confirm that use of a drug name along with its pharmacologic classification (eg. 'diuretic') is exempt from PAAB review? The therapeutic classification (eg. 'antihypertensive') would not be included, as this alludes to therapeutic use.
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729 - Can you please confirm that use of a drug name along with its pharmacologic classification (eg. 'diuretic') is exempt from PAAB review? The therapeutic classification (eg. 'antihypertensive') would not be included, as this alludes to therapeutic use.

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Please see answer to question 467.

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