Exeed Regulatory Compliance

MARCH 5, 2020

It rapidly caused a widespread epidemic in China and has spread to over 50 countries outside of China with more than 90,000 confirmed cases and 3000 deaths at the time of this blog article. This is where FDA’s Emergency Use Authorization (EUA) comes into play and offers an opportunity for the medical industry to rally and help.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

Drug & Device Law

JANUARY 30, 2023

For those of you accessing the Blog on mobile devices, this post may be hard to read. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. continue to be subject to Rule 407-based exclusion.

FDA 52

FDA Governance 52