I do not have specific information, but I have heared that Pfizer and GSK filed MODRs.

Join Dr. Joachim Ermer (Ermer Quality Consulting) to learn more about Practical Examples and Regulatory Expectations for the Validation of Biotechnological Analytical Methods – Linearity Testing, Total Error Approach.

Watch the On-Demand presentation now: https://bio-qc.com/practical-examples-and-regulatory-expectations-for-the-validation-of-biotechnological-analytical-methods-linearity-testing-total-error-approach/  

Plus, don’t miss his expert insights during the panel discussion on Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14.