Elite Pharmaceuticals Inc (ELTP): That was for medical devices, not the pr...

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Re: None

Sunday, 12/18/2016 7:32:22 PM

Sunday, December 18, 2016 7:32:22 PM

That was for medical devices, not the process for FDA CBER meetings.
The link below is guidance for CRL and timeframes for actions that ELITE would have to take and the timeframe for FDA reviews after resubmission.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.110

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