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
Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations.
Generic preemption remains a hot topic. In Storm...more
10/10/2015
/ 510(k) RTA ,
Device Classification ,
Drug Safety ,
Failure To Warn ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Pharmaceutical Industry ,
Preemption ,
Product Labels ,
Transvaginal Mesh