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

Prevision Policy Clips | CMS Prepares For Oz: New Leadership Posted Online Includes Acting Administrator

FDA Guidances Have Been Edited To Comply With “DEI” Orders – But With No Notice Of Updates; HHS-Wide Communications “Pause” Continues

Prevision Policy Clips | Kennedy Confirmation Vote For HHS Set For Feb. 4 In Finance Committee

Project Orbis Update: FDA Approves 23 Products Under Global Oncology Collaboration In 2024; Imfinzi Label Expansion Includes EMA As “Observer”

Prevision Policy Clips | Date Change: Prevision Policy/Friends Of Cancer Research Biopharma Congress Will Take Place April 7

HHS Vaccine Policy Stakes Made Clear During Senate HELP Hearing With RFK; Significant Adverse Impacts On Uptake Likely – Unless Issue Prevents His Confirmation

Prevision Policy Clips | Kennedy Confirmation Hearing Showcases Bipartisan Support For PBM Reform Legislation

RFK Confirmation Hearing Underscores Risks For Biopharma: “Overmedication” Is Key Theme, As Are Price Cuts; Kennedy Somewhat Softens Threatening Tone Towards FDA

Prevision Policy Clips | Federal Workforce Uncertainty Increases With “Buyout Offer”

Advisory Committee Tracker: Meetings Lost In Transition; Will Advisory Committee “Re-Set” Ever Occur?

Prevision Policy Clips | FDA Gag Order Now Extends To February 22

Prevision Policy Clips | FDA, NIH, CDC And CMS All Have “Acting” Directors

CMS “Fit-For-Purpose” RWE Guidance Includes Template For Study Protocols; Intended For Devices But Could Be Expanded To Drugs—If Administration Agrees