Major USFDA Regulatory Updates in April 2023
On April 05, FDA issued draft guidance on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or...
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Antero Pharma Consultant
- Mar 28
- 2 min
Expanded Access Program - overview and notes
What is an Expanded Access program? Expanded access or Compassionate use is the FDA program by which a doctor or registered physician can...
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Antero Pharma Consultant
- Jan 13
- 2 min
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On December 02, FDA issued draft guidance on "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug...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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