This week FDA posted one letter to a fertility clinic, two to drug manufacturers, and one to a compounding pharmacy, and we cover those here.
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.
Issued this week were two untitled letters from CBER and two warning letters to implant manufacturers.
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.”
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.
The first quarter of 2020 is behind us, and with it, a fresh batch of warning letters sent by the FDA to food and dietary supplement companies.
We’ve compiled a snapshot of all of the letters that posted from January through the end of March and organized them by category provided by the FDA for your convenience. In total, 22 warning letters were sent for various infractions, ranging from FSVP violations to Insanitary Conditions.
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.