A bipartisan coalition of 23 state attorney generals led by Virginia AG Jason Miyares recently went up in arms about a products liability ruling they believe will threaten state consumer protection laws. On May 30, the...more
6/16/2023
/ Life Sciences ,
Merck ,
Pharmaceutical Industry ,
Preemption ,
Prescription Drugs ,
Product Defects ,
Regulatory Agenda ,
Regulatory Oversight ,
State Attorneys General ,
State Sovereignty ,
Unfair or Deceptive Trade Practices
On March 23, New Jersey Gov. Phil Murphy issued Executive Order 109 — the state’s latest directive relating to COVID-19. ...more
3/24/2020
/ Coronavirus/COVID-19 ,
Elective Surgical Procedures ,
Executive Orders ,
Goods or Services ,
Life Sciences ,
Medical Devices ,
Medical Supplies ,
Pharmaceutical Industry ,
Relief Measures ,
State and Local Government ,
Supply Chain
A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients.
Originally published in Update magazine - August/September 2018....more
8/22/2018
/ Big Data ,
Electronic Medical Records ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Innovation ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
Patent protection can be critical for health care products, including medical devices, prescription drugs, dietary supplements and software as a medical device (SaMD).
Originally published in Law360 - September 8, 2017....more
Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more
10/6/2017
/ Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Big Data ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medical Devices ,
Off-Label Promotion ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Standards ,
Value-Based Payments