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No, that’s not correct. The guidance is also

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MedResCollab   Wednesday, 07/10/19 09:55:24 PM
Re: ggwpq post# 200979
Post # of 339101 
No, that’s not correct. The guidance is also quite clear on this.

Quote:
...Solicited amendments [requested by FDA; i.e. blood pressure data from REDUCE-IT?] are usually reviewed during the current cycle provided they are received early enough. The RPM processes the amendment and distributes it to the review team.

Extending the Review Clock: A major amendment (e.g., a significant amount of new information, new analyses, new study or trial report) can extend the review clock (PDUFA goal date) three months. The review team decides whether to extend the review clock and review the information or defer review to a subsequent review cycle. This decision should be based, in part, on whether the amendment has the potential of bringing the application into condition for approval. If there are deficiencies that cannot be addressed by the amendment, the division should generally defer review of the amendment until a subsequent review cycle without extending the review clock. If the review clock is extended, the RPM sends an Extension Letter to the applicant to notify them of the new goal date.



Many an example, such as:

https://www.globenewswire.com/news-release/2019/06/06/1865633/0/en/Xeris-Pharmaceuticals-Receives-Notification-of-PDUFA-Date-Extension-for-Gvoke.html

Regards,
-MRC

...
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