Former FDA Official David Doleski on Agency Hot Button Issues and Developing a Positive Relationship
After nearly 28 years at FDA—in review, inspection, and compliance positions—David Doleski, now Compliance Head for Biologics Quality Operations at Sanofi, provided his perspectives into how regulators think during his keynote presentation at the ISPE Aseptic Conference in early March 2020.
This week FDA posted three warning letters to drug firms, one to a device firm, and one to a compounding pharmacy. We cover these five here.
We review the in-depth coverage from FDLI’s December conference provided by Govzilla’s Senior GMP Expert Jerry Chapman.
Issued this week were two untitled letters from CBER and two warning letters to implant manufacturers.
Join Lead Quality Systems and Compliance Consultant Steven Niedelman for a comprehensive webinar on what to expect during an inspection as well as the “Do’s and Don’ts” during an inspection.
This week, FDA issued 42 warning letters to firms and individuals who distribute unapproved new drugs to prevent or treat COVID-19 infections, as well as two untitled letters and five warning letters to pharma/device firms.