I have posted this information before and received

I have posted this information before and received replies claiming that I am wrong. However, I'm not sure anyone has really provided adequate proof to the contrary. So it is in this context that I post this information again.

I think that document states the review process starts all over again.

Source Link: https://www.fda.gov/media/78941/download


PDF Page 23 / Paper Page 19

Quote:

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3.2.2 Refusal to File (RTF)If application deficiencies cannot be rectified readily, an RTF should be considered. If an RTF decision is anticipated, the division director and the office director are notified and issues are discussed prior to the filing meeting. FDA has generally exercised its RTF authority in circumstances identified in Appendix B

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PDF Page 24 / Paper Page 20

Quote:

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A refusal-to-file decision ends the review process. The applicant’s options are to resubmit the NDA/BLA with the deficiencies addressed (the resubmission is considered an original new application) or to request that the NDA/BLA be filed over protest. PDUFA V “Program” applications that are subsequently filed over protest are removed from “The Program” and become subject to the standard 6- or 10-month review clock, as applicable. The applicant must be notified of a refusal-to-file decision (via RTF letter) within 60 days after the original receipt date of the application.

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As usual, I am happy to be proven wrong -- especially in this particular instance.