Resources

In June, CBER Division of Manufacturing and Product Quality Facilities Reviewer and Investigator Ekaterina Allen spoke at the ISPE Biopharmaceutical Manufacturing conference about the current regulatory landscape for cell and gene therapy products.Part I covered her remarks about the current manufacturing challenges.This is the second part of the series and it looks at the most […]

At the FDA/PharmaLink conference earlier this year, representatives from the Russian State Institute of Drugs and Good Practices (SID&GP), UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and U.S. FDA shared their top ten pharma company inspection findings from FY2019, revealing many similarities and a few differences. [Related: Download the author’s 2020 webinar on this […]