On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Showing posts with label
PDUFA
.
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Showing posts with label
PDUFA
.
Show all posts
Saturday, June 17, 2023
Regulatory Education for Industry (REdI) Annual Conference 2023 - Slides and Recordings
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Early this month, FDA conducted 'Regulatory Education for Industry (REdl) Annual Conference 2023'. This annual conference provided ...
Saturday, March 11, 2023
Critical Dates after NDA/BLA submission: Filing Date (Day 1), Day 14, Day 60, Day 74, and PDUFA date
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After the NDA/BLA is submitted to FDA, the FDA review clock starts. There are several critical dates relevant to the applicant (the sponsor)...
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