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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

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

January 31, 2025

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

January 31, 2025

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

January 30, 2025

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

January 30, 2025

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

January 29, 2025

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

January 29, 2025

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

January 28, 2025

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

January 28, 2025

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

January 27, 2025

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

January 24, 2025

Prevision Policy Clips | It’s (Almost) Official: Sara Brenner Is Now FDA Principal Deputy Commissioner

January 24, 2025

BsUFA Regulatory Science Pilot Seeking Partners For Human Factors Research; Interim Report Coming Before Planned September Meeting; Update Event Happens Despite Communications Freeze

January 23, 2025

FDA Diversity Action Plans In Limbo, OCE “Project Equity” Webpage Goes Dark As Trump Executive Order On DEI Takes Effect

January 23, 2025

Prevision Policy Clips | HHS Confirmation Hearing Set For January 29: Robert Kennedy’s

January 23, 2025

“Acting” FDA Commissioner Brenner Brings Trump White House-Level COVID Response Experience, Expertise In Nanoscience To Interim Role

January 22, 2025

Prevision Policy Clips | Communication Blackout At FDA Amid Transition

January 22, 2025

Prevision Policy Clips | HHS Acting Head Is Dorothy Fink; FDA Leadership Still Unannounced

January 21, 2025

Price Negotiation Class Of 2027 Includes Four Oncologic Agents; GSK, AbbVie, BI And Pfizer Have Multiple Products Selected; Ozempic Is The Headliner

January 17, 2025

Prevision Policy Clips | GSK, BI, AbbVie and Pfizer Each Have Two Drugs Up For Negotiation In Year 2

January 17, 2025
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