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.
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.
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.
FDA posted three drug GMP warning letters this week to pharmaceutical firms, one to a compounding pharmacy, one to a GLP site, and two to device manufacturers.
On Friday, March 13, 2020 Covington & Burling hosted a Briefing Call titled “COVID-19: Evolving Considerations for the Life Sciences Industry” spearheaded by the firm’s Food, Drug and Device industry practice. The discussion was wide-ranging and made some important points. We cover these here.
This week we cover three warning letters: two to pharma firms and one to a clinical investigator.