On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) regarding speaker programs hosted by pharmaceutical and medical device companies. Speaker programs are company-sponsored...more
In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look...more
10/22/2020
/ Bayh-Dole Act ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Approvals ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Telehealth
During this unprecedented time, digital health is disrupting our healthcare delivery system for the better. Digital health companies are working hard to provide innovative telehealth, digital screening, and testing services....more