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Fda
Nov 5, 2013 7:58:00 GMT -5
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Post by sammy967 on Nov 5, 2013 7:58:00 GMT -5
I wonder why FDA said that they acknowledged of receiving nda. Why they did not just accepted Nda. Never heard of acknowledgement. Usually FDA says they accept nda. Thank you for your opinion.
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Fda
Nov 5, 2013 12:06:21 GMT -5
Post by brentie on Nov 5, 2013 12:06:21 GMT -5
I wonder why FDA said that they acknowledged of receiving nda. Why they did not just accepted Nda. Never heard of acknowledgement. Usually FDA says they accept nda. Thank you for your opinion. Sammy,I think it's because it's not the original new drug application submission, it's a resubmission of the NDA. ---------------------------------------------------------------------------------------------------------------------------------- If the resubmission is complete: Ensure the review clock was started upon receipt once the review team confirms that the resubmission is complete and the designation of “response to CR letter” is selected in the regulatory database. [RPM] Determine initially whether or not the amendment is a Class 1 or Class 2 Resubmission if the applicant indicates a complete response for a PDUFA application or efficacy supplement. Note: Class 1 or Class 2 designations do not apply to: manufacturing or labeling supplements, non user fee or biosimilar biuological products. [RPM] Confirm Class 1 or Class 2 category if the resubmission responds completely to an action letter for a PDUFA application or efficacy supplement. [Review Committee Members] *****Send a Resubmission Acknowledgement Letter for an original application within 14 calendar days of receipt and for efficacy supplements within 30 days of receipt, as resources permit, indicating the new action due date to the applicant. [RPM] Acknowledge a resubmission for a labeling or manufacturing supplement by telecon, email, or letter. [RPM] www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm073490.htm
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Fda
Nov 6, 2013 0:55:45 GMT -5
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brentie likes this
Post by sammy967 on Nov 6, 2013 0:55:45 GMT -5
Thank You
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