2003, FDA, Governance and Licensing - Health Care Compliance Brief

NPP, DCC, And FDA-Regulated Medical Products

Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. Both talk a fair amount about “commerce” and the respective roles of the states and federal government. 644 (2003), but not to Pike. Walsh , 538 U.S.

FDA

FDA Licensing Doctors Governance

The FDA and Feasible Alternative Designs

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

FDA Licensing Hospitals Governance

Health Care Compliance Brief

NPP, DCC, And FDA-Regulated Medical Products

The FDA and Feasible Alternative Designs

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