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Prevision Policy Clips | FDA Layoffs Begin: Device Center Appears More Affected In Round One
February 18, 2025
The Kennedy HHS Era Begins With FDA Staff On Edge: “MAHA” Commission Launches With Anti-Industry Themes – But Better Than Some Alternatives
February 14, 2025
Prevision Policy Clips | HHS Secretary Kennedy Defuses Rumors Of 50% Cuts In Staff, But Leadership Purge
February 14, 2025
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
February 13, 2025
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
February 13, 2025
Prevision Policy Clips | FDA/NIH Rare Disease Still On For February 27-28, With Key FDA Officials On Agenda
February 13, 2025
HTA Harmonization? ICER Teams Up With British NICE and Canada’s Drug Agency To Form Partnership To Assess New Health Economics Methods
February 12, 2025
Prevision Policy Clips | DOGE Layoff Order Unveiled, But No Targets Set For FDA
February 12, 2025
The End Of The User Fee Era? DOGE, Budget Cuts Could Undo Core FDA Regulatory Model
February 11, 2025
AI Regulation At FDA May Drive Drug/Device Regulatory Convergence; Guidance Development Highlighted As Key For Field At FOCR Meeting
February 11, 2025
Prevision Policy Clips | FDA Warns Of Medication Errors With Tranexamic Acid Injections, Opens Investigation
February 11, 2025
Prevision Policy Clips | FDA Issues A Guidance: IRB “Checklist”
February 10, 2025
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
February 7, 2025
Prevision Policy Clips | FDA Facing Mass Layoffs? White House Plans Executive Order To Fire HHS Employees
February 7, 2025
Vertex Non-Opioid Pain Product Receives Favorable Notice In House Illicit Drugs Hearing; Will FDA Retain Bipartisan Support Amid Trump Transition?
February 6, 2025
Medicare Part D Stability Drawing More MedPAC Attention; Decline In Standalone Plans May Be Threat To Fee-For-Service Medicare
February 6, 2025
Prevision Policy Clips | CMS Gets DOGEd: Agency Says Two Officials Are Chaperoning
February 6, 2025
Prevision Policy Clips | RFK Confirmation Vote For HHS Likely The Week Of February 10
February 5, 2025
Vaccine Safety Commission Will Likely Be Early Action By Kennedy HHS; Will Commitments To Cassidy Hold The Line On More Drastic Action?
February 4, 2025
Vertex “Breakthrough” Non-Opioid Pain Treatment Journavx Breaks Through FDA Communication Blackout; Pregnancy Safety Will Be Post-Market Activity
February 4, 2025
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
February 4, 2025
Kennedy Keeps It Vague: HHS Nominee Moving Forward Without Much Clarity On Drug Pricing Plans Or How “MAHA” Will Translate To Policy
February 4, 2025
Prevision Policy Clips | CMS Prepares For Oz: New Leadership Posted Online Includes Acting Administrator
February 4, 2025
FDA Guidances Have Been Edited To Comply With “DEI” Orders – But With No Notice Of Updates; HHS-Wide Communications “Pause” Continues
February 4, 2025
Prevision Policy Clips | Kennedy Confirmation Vote For HHS Set For Feb. 4 In Finance Committee
February 3, 2025
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