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  3. Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
  4. 368 - We have an existing product with a new indication. We would like to announce the 'new' indication like "Now indicated in...". What level of fair balance would be required?
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368 - We have an existing product with a new indication. We would like to announce the 'new' indication like "Now indicated in...". What level of fair balance would be required?

Scheduled Pinned Locked Moved Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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  • Jennifer CarrollJ Online
    Jennifer CarrollJ Online
    Jennifer Carroll
    wrote on last edited by
    #1

    If that's the only message conveyed (both explicitly and implicitly), you'd need the indication and the lowest level fair balance.

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