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For purposes of this section, a clinical investigation is considered to be “on-going” if it is ongoing and the sponsor has not yet submitted the protocol for the expanded access use. For purposes of submitting a protocol for expanded access, the sponsor may treat the clinical investigation as ongoing. If, for any reason, the sponsor does not continue the expanded access use within the sponsor’s planned timeframe, the sponsor shall submit a revised application. The revised application shall include all of the information required for a new application and all of the information required for the initial protocol. The sponsor should request that the clinical investigation be suspended until the sponsor has submitted the revised application.
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