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
It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more
7/17/2018
/ 21st Century Cures Act ,
Affordable Care Act ,
Client Services ,
Depositions ,
DQSA ,
Emergency Response ,
Enforcement Actions ,
FDASIA ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Innovation ,
Juror ,
Jury Trial ,
Law Firm Associates ,
Law Firm Ownership ,
Law Firm Partners ,
Law Practice Management ,
Manufacturers ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
Multidistrict Litigation ,
Patient Rights ,
Patient Safety ,
Patients ,
Pharmaceutical Industry ,
Preemption ,
Questionnaires ,
Reporting Requirements ,
State Law Tort Claims ,
Voir Dire ,
Witness Preparation