One of the spillover effects of the COVID-19 pandemic has been the increase in opioid-related deaths. These deaths overwhelmingly affect working-class Americans with limited access and resources to lifesaving drugs such as...more
6/10/2021
/ Biden Administration ,
Certification Requirements ,
DEA ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
Notice of Intent ,
Opioid ,
Prescription Drugs ,
SAMHSA
Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more
1/29/2021
/ Biden Administration ,
CARES Act ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Orange Book ,
PDUFA ,
Pharmaceutical Industry ,
Public Health Service Act ,
Regulatory Agenda
In the midst of the pandemic emergency, the Department of Health and Human Services Office of Inspector General (OIG) issued a stern warning about in-person educational programs for health care professionals (HCPs), known as...more
11/30/2020
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Fraud Alerts ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Remuneration ,
Speaker Programs
The Food and Drug Administration (FDA) continues to churn out policy statements, guidance documents, and emergency use authorizations (EUAs) to address the COVID-19 public health emergency. At the outset of the pandemic in...more
Despite congressional attention, Food and Drug Administration (FDA) action, public and private sector efforts, and ongoing media coverage, drug shortages remain a significant public health crisis in the United States. In...more