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APhA Policy Manual


APhA supports the adoption of policies in the new drug application (NDA) process that, beyond the pre-market clinical testing, would result in post-marketing, clinical testing of the drug for important new clinical uses or population groups. Post-marketing studies may also be preferable for other indications where circumstances may require a lengthy gathering of data due to limitations in numbers of clinical cases, and for which initial marketing approval for the major indication(s) or population groups should not be delayed.

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