Prevision Policy Clips | CBER Gene/Cell Therapy Leadership Team Appears Set For First Public Presentations Of Trump Era

Make HHS Anti-Industry Again? Kennedy Blames “System, Not The People,” For “Inefficient, Dysfunctional Or Corrupt” Agencies In First Address To Staff

Prevision Policy Clips | Disrupting FDA: Agency Managers Unsure Of Who Is Laid Off Until Notified By Affected Staff

Prevision Policy Clips | FDA Layoffs Begin: Device Center Appears More Affected In Round One

The Kennedy HHS Era Begins With FDA Staff On Edge: “MAHA” Commission Launches With Anti-Industry Themes – But Better Than Some Alternatives

Prevision Policy Clips | HHS Secretary Kennedy Defuses Rumors Of 50% Cuts In Staff, But Leadership Purge

White House Supports Shutdown Model For DOGE Cuts; Musk Says Cuts Will Be Made “In Partnership” With Agency Heads; UCSF’s Prasad Rumored To Be Seeking FDA Role

FDA RMAT Designations Spiking: Agency Granted 43 Requests In FY 2024 And Nine More In First Quarter Of FY ‘25; RMAT Approvals Now Total 13

Prevision Policy Clips | FDA/NIH Rare Disease Still On For February 27-28, With Key FDA Officials On Agenda

HTA Harmonization? ICER Teams Up With British NICE and Canada’s Drug Agency To Form Partnership To Assess New Health Economics Methods

Prevision Policy Clips | DOGE Layoff Order Unveiled, But No Targets Set For FDA

The End Of The User Fee Era? DOGE, Budget Cuts Could Undo Core FDA Regulatory Model

AI Regulation At FDA May Drive Drug/Device Regulatory Convergence; Guidance Development Highlighted As Key For Field At FOCR Meeting

Prevision Policy Clips | FDA Warns Of Medication Errors With Tranexamic Acid Injections, Opens Investigation

Prevision Policy Clips | FDA Issues A Guidance: IRB “Checklist”

DOGEing FDA: Layoff Threat Looms, With Prospect Of Significant Disruption; Here Are Two Scenarios For What Massive Cuts Could Look Like In The Long Run

Prevision Policy Clips | FDA Facing Mass Layoffs? White House Plans Executive Order To Fire HHS Employees

Vertex Non-Opioid Pain Product Receives Favorable Notice In House Illicit Drugs Hearing; Will FDA Retain Bipartisan Support Amid Trump Transition?

Medicare Part D Stability Drawing More MedPAC Attention; Decline In Standalone Plans May Be Threat To Fee-For-Service Medicare

Prevision Policy Clips | CMS Gets DOGEd: Agency Says Two Officials Are Chaperoning

Prevision Policy Clips | RFK Confirmation Vote For HHS Likely The Week Of February 10

Vaccine Safety Commission Will Likely Be Early Action By Kennedy HHS; Will Commitments To Cassidy Hold The Line On More Drastic Action?

Vertex “Breakthrough” Non-Opioid Pain Treatment Journavx Breaks Through FDA Communication Blackout; Pregnancy Safety Will Be Post-Market Activity

CMS Prepares For Oz: Former Finance Staffer Carlton Is “Acting” Administrator And Expected To Be Chief Of Staff; Trump 1.0 Veterans Brooks, Brandt And Sutton Return

Kennedy Keeps It Vague: HHS Nominee Moving Forward Without Much Clarity On Drug Pricing Plans Or How “MAHA” Will Translate To Policy