In the areas we cover, FDA posted three drug GMP warning letters including one sent to a fertility clinic governed by HCT/P regulations. The other two firms manufacture OTC products. FDA also posted a warning letter to a firm in Ireland, Carahealth, for distributing unapproved and misbranded products related to coronavirus disease.
FDA posted four warning letters in areas we cover: two to pharma firms, including the one to Cipla Limited we’ve been watching for, and two to HTC/P manufacturers. The other pharma warning letter serves as an egregious example of data integrity deficiencies.
Big Pharma Puts Patients First in Response to COVID-19 Challenges; Collaboration with Regulators is Essential Going Forward
The challenges to pharma companies from COVID-19 and how they continue to respond was a topic raised at the FDA/Xavier PharmaLink conference, which was held March 17-20, 2020. Challenges discussed included uninterrupted supply of medicines, risk management plans, relationships with regulators, and animal trials.
A serious concern of many is the security of their supply chain based on its complexity and global nature. We look at the GMP audit program and some options that may be able to help mitigate risk in this area, as well as explain choices made that may be asked during the next health authority inspection.
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.