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Approvable and Not Approvable Letters Discontinued

07/10/2008

Federal Register Final rule: FDA is amending its regulations on NDAs and ANDAs by discontinuing its use of approvable letters and not approvable letters when taking action on marketing applications. Instead, the agency will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. To view this final rule, click here.

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