On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved...more
The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more
2/13/2023
/ False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Private Equity ,
Telemedicine
Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence (RWE). The procedural guidance aims to...more
Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more
4/26/2022
/ Consumer Product Safety Commission (CPSC) ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Fraud ,
Opioid ,
Pfizer ,
Pharmaceutical Industry ,
Popular ,
Purdue Pharma ,
Vaccinations
Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on managing IP development and capture at growing medtech start-ups that offers insight from executives at...more
President Joe Biden was sworn into office on January 20, 2021. As with any incoming administration, new policies will be pursued while those of the previous administration are furthered, abandoned, or undone. The federal...more
3/1/2021
/ Biden Administration ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Costs ,
Hospitals ,
Physicians ,
Popular
On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that, if finalized, would entail changes in Medicare coverage. (“Medicare Coverage of Innovative Technology (MCIT) and Definition...more
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