With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
4/28/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Medical Devices ,
New Legislation ,
Prescription Drugs ,
Regulatory Reform ,
Tariffs
On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more
3/7/2025
/ Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Notice and Comment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Authority ,
Regulatory Reform ,
Regulatory Requirements ,
Rulemaking Process
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and...more