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Negotiations about the 2022 reauthorization counsel that marketplace priorities consist of greater software of genuine-entire world proof, regulatory certainty, and increased communication in between FDA and market in the drug software course of action.

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Every single PDUFA reauthorization makes a “need to pass” legislative auto on which marketplace can concentrate its Electrical power and lobbying efforts, which Congress ought to then think about and vote on in a confined time period, constraining its capability to considerably revise the commitments ensuing from FDA-field negotiation.

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