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.
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.”
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.
Among the warning letters we follow, this week FDA posted one to a drug manufacturer, two to device firms, and one to a clinical investigator conducting studies on a device.
Enforcement this week included a collection of warning letters including three device warning letters and three drug GMP warning letters, including one to a fertility clinic governed under 21 CFR 1271. And, warning letters to firms touting treatments for the coronavirus disease finally started appearing.
After three weeks of no warning letters, this week the FDA posted five drug GMP warning letters and three device GMP warning letters.
We cover one device warning letter and review a mislabeling of PURELL Hand Sanitizer.