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
On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued new regulatory waivers and rule changes aimed at expanding access to care and allaying regulatory burdens on healthcare providers during the...more
On April 19, 2020, the Centers for Medicare & Medicaid Services (CMS) issued Phase 1 of recommendations for re-opening certain healthcare facilities that provide non-emergent healthcare following COVID-19 related...more
On March 27, 2020, President Trump signed Public Law 116-136, the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), the federal government's latest and most ambitious response to the COVID-19 crisis. As yet,...more