SQA

AUGUST 8, 2023

In August 2022, ANVISA published Resolution RDC 741/2022 , which sets the framework to consider other medical device market regulators’ authorizations. The affected lots of Emerade were distributed in Canada between April 2022 and May 2023. Recalls All Lots of Emerade Epinephrine Auto-Injectors (0.3 mt and 0.5 mg and 0.5

FDA 40

FDA Compliance COVID-19 World Health 40

Drug & Device Law

DECEMBER 12, 2022

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. GlaxoSmithKline PLC , 2022 WL 17338047 (E.D.N.Y. 29, 2022), which (if allowed to stand) imperils everything that Congress and the Supreme Court accomplished through the Vaccine Act. Merck & Co.

FDA 115

FDA Public Health Fraud Hospitals 115

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA 59

FDA Licensing Hospitals Governance 59