ARTICLES BY BIKASH CHATTERJEE
Navigating The FDA’s Emergency Use Authorization Process5/14/2020
The FDA has been authorized to grant Emergency Use Authorizations for SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ.
Ensuring Quality In Ventilator Production Scale-Up For COVID-194/24/2020
Chief Editor Louis Garguilo asked Outsourced Pharma Advisory Board member and COO/CSO of Pharmatech Associates, Inc., Bikash Chatterjee, to update our readers periodically on what he is seeing and experiencing during this coronavirus pandemic. This is his first update.
Best Practices For Measuring System Quality For Drug-Device Combination Products7/19/2017
Combination product development is a complex matter governed by different areas of regulatory oversight. In my previous article, we discussed which current good manufacturing practice (cGMP) requirements apply when drugs, devices, and biological products are combined, and the typical pitfalls to avoid when doing so.
Managing QMS Disparities Between Drugs And Devices For Combination Products7/14/2017
Combination products represent a remarkable opportunity as one of the most dynamic segments in the life sciences and are projected to grow to $115 billion by 2019.