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.
We review the in-depth coverage from FDLI’s December conference provided by Govzilla’s Senior GMP Expert Jerry Chapman.
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.
We provide an overview and analysis of the two drugs granted EUA for COVID-19, including notes on CGMPs and a whistleblower complaint.
Avoiding and Reacting to Human Tissue, Cell and Gene Therapy Enforcement Actions: Communication is Key
“The beauty of the TRIP program,” Laney said, “is that it is informal and non-binding. It is an open forum for tissue manufacturers and processors to talk to the agency and get advice in a way that fuels open communication on a rapid-response timeline.”
FDA continues their effort to limit the sale of unauthorized electronic nicotine delivery devices by posting ten warning letters last week to firms who target teenagers and other youth. They also continue to issue warning letters to firms that are advertising and distributing unapproved drug products for the prevention and treatment of COVID-19 infection.
No warning letters to drug firms were posted this week. One warning letter was issued to a device firm and one untitled letter was issued to a stem cell firm.