I. Introduction -
Since the United States Supreme Court’s decision in Pliva, Inc. v. Mensing, the plaintiffs’ bar has been feverishly searching for an alternate theory of recovery when the claimant took a generic...more
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