Does PAAB have a specific guidance document for what it considers as "consistent with the TMA"? If not, do you use the principles from the FDA's CFL guidance?
R
rlevit1
@rlevit1
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consistent with TMA -
Lives covered by private insurance messageAs "lives covered" data can evolve with time as new insurance companies are added, is the expectation to submit an updated tool to PAAB every time, or it can be approved with X% with a note that data will be updated without PAAB review?
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NEW PAAB Logo RevealedLooks great!