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.
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.
We cover one device warning letter and review a mislabeling of PURELL Hand Sanitizer.
The FDA 510(k) Program, also referred to as premarket notification, is an FDA marketing clearance application and is the most common avenue of premarket submission for medical devices. This article serves to provide you with a high-level understanding of the items required in 510(k) submissions and resources to help you during the process.
Upcoming Webinar: It’s Not All on the Web – Finding the FDA Information You Didn’t Know You Could Have
Join President of FOI Services, Marlene Bobka, for an informative 1-hour webinar about all things FOIA. Gain a deeper understanding of the internal workings of FDA and help prevent legal actions, financial penalties and other costly errors at your company.
Given that the size of the pharmaceutical industry at times overshadows the medical device market, it is no surprise that companies that are just getting