SAFETY REPORTING THROUGH PSUR/PBRER
A brief history of PSUR/PBRER In November 1996, ICH endorsed the ICH E2C (R1) Periodic Safety Update Report Guideline that established...
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Antero Pharma Consultant
- Dec 21, 2022
- 2 min
Major USFDA Regulatory Updates in December 2022
On December 02, FDA issued draft guidance on "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug...
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shai293
- May 16, 2022
- 2 min
Position Your Biotech Asset for Success Using The Project Management Toolkit.
The auto industry was one of the first large industries to apply project management (PM) principles. Historically, drug development...
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