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.
We provide an overview and analysis of the two drugs granted EUA for COVID-19, including notes on CGMPs and a whistleblower complaint.
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.
This report presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.
Among the areas we cover, FDA posted one warning letter issued to a fertility clinic governed by the HCT/P regulations and one to a compounding pharmacy.