In the simplest case for federal preemption, federal law prohibits conduct that a state tort duty would require, such as a change in the design of an approved medical device to cure an alleged defect. Because federal law is...more
6/21/2019
/ Biosimilars ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Labeling ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
PLIVA v Mensing ,
Preemption ,
SCOTUS
In this issue of Pro Te (Volume 11, No.2), we examine three important topics with practical implications.
In many jurisdictions, the medical judgment of physicians is almost sacrosanct – at least insofar as it is...more
9/21/2018
/ 21st Century Cures Act ,
Dismissal With Prejudice ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Medical Devices ,
New Guidance ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Regulatory Oversight ,
Statute of Limitations