On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an Interim Final Rule (IFR) with Comment Period, 86 Fed. Reg. 61555 (Nov. 5, 2021), requiring mandatory COVID-19 vaccination of staff of many...more
11/12/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Liability Issues ,
Employer Mandates ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Home Health Care ,
Human Resources Professionals ,
Infectious Diseases ,
Long Term Care Facilities ,
Vaccinations ,
Workplace Safety
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