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12/12/12
08:26
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for anyone who's interested, the FDA resubmission procedure...
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082002.pdf
the CDER classifies resubmissions into one of two categories:
- class 1: 2 month review
- class 2: 6 month review
they advise which class they have assigned to the resubmission 14 days after submission.
interestingly class 1 resubmissions includes...
''8. A minor re-analysis of data previously submitted to the application (determined by the FDA as fitting the Class 1 category)''.
I guess they already have a feeling that it will be a 'non-minor' review and will take 6 months.
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