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.
Lots of warning letters this week issued by the Center for Tobacco Products, including 22 to firms selling flavored, cartridge-based electronic cigarettes. FDA also posted one issued to a drug manufacturer and one to a clinical investigator. We cover the latter two here. And, the Cipla warning letter we referenced last week has not been posted yet.
At the FDLI conference held in Washingon, DC in December 2019, CDER Office of Compliance (OC) Director Donald Ashley reviewed FDA’s enforcement firsts from FY 2019.
On Wednesday, March 11, 2020, the World Health Organization declared the spread of the respiratory illnesses caused by the novel coronavirus a pandemic. Here’s how it’s impacting some pharma and device firms.
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.