Antero Pharma ConsultantMay 212 minMajor USFDA Regulatory Updates in April 2023On April 05, FDA issued draft guidance on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or...
Antero Pharma ConsultantMar 282 minExpanded Access Program - overview and notesWhat is an Expanded Access program? Expanded access or Compassionate use is the FDA program by which a doctor or registered physician can...
Antero Pharma ConsultantJan 132 minSAFETY REPORTING THROUGH PSUR/PBRERA brief history of PSUR/PBRER In November 1996, ICH endorsed the ICH E2C (R1) Periodic Safety Update Report Guideline that established...
Antero Pharma ConsultantDec 21, 20222 minMajor USFDA Regulatory Updates in December 2022On December 02, FDA issued draft guidance on "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug...
shai293May 16, 20222 minPosition 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...