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MASH Histology Assessment AI-Assisted Tool Approved In Europe; Biomarker’s Qualification Is Ongoing At FDA
April 22, 2025
Nanoscope Retinitis Pigmentosa Treatment Would Benefit From Value-Based Contracting, ICER Says; Panel Revisits Ophthalmic Gene Therapy Seven Years After Luxturna
April 22, 2025
Prevision Policy Clips | OCE Loses Two More: Associate Director For Biomarkers And Precision Oncology Reena Philip
April 22, 2025
Conditional Approval Pathway For Ultra-Rare Conditions Based On “Plausible Mechanism” Floated By FDA Commissioner Makary
April 21, 2025
Prevision Policy Clips | CMS Center For Medicare Director Is John Brooks
April 21, 2025
FDA Advisory Committee Industry Reps Sacrificed To “Radical Transparency”; Commissioner Makary Defends FDA Cuts In On-Line Interview
April 18, 2025
Prevision Policy Clips | No More Industry Reps: FDA Advisory Committees Will No Longer Have Company Executives
April 18, 2025
CAR-T Differences Debated Again In CMS Discussion Of NTAP Applicants For FY 2026; 13 Drugs Seek New Technology Add-On Payments
April 17, 2025
Prevision Policy Clips | HHS Draft Budget Proposal Protects User Fee “Triggers,” But Cuts FDA Appropriations
April 17, 2025
Improving The IRA: Trump Drug Pricing Executive Order Has Many Positives For Pharma, Though HHS Demo Is Threat To Monitor; Policy Menu Largely Unchanged From 2017
April 16, 2025
Prevision Policy Clips | Improving The IRA: Trump Drug Pricing Executive Order Includes Call To End “Pill Penalty”
April 16, 2025
Prevision Policy Clips | FTC Looking To Roll Back “Anti-Competitive Regulations”
April 15, 2025
Saving Part D: MedPAC Debates Ways To Make Stand-Alone Plans More Viable; Warns That Future Of Traditional Medicare May Be At Stake
April 14, 2025
Fixing Biosimilars: Stelara Will Be Test Of Price Negotiation Impact; FDA Cuts May Have Significant Adverse Effect At Tough Time For Sector
April 14, 2025
“A Slow Moving Catastrophe”: FDA Layoffs Will Result In Less Guidance And Less Flexibility, Ex-Leaders Suggest; Cell/Gene Therapy Could Be A Bright Spot
April 14, 2025
Prevision Policy Clips | Digital Health Technologies In Clinical Trials: FDA Viewpoint Posted In JAMA
April 14, 2025
FDA “Five-Office” Reorg Proposal Criticized By Former Senior Officials; Regulatory Work Is Too Specialized For A “Big Team Of Generalists”
April 11, 2025
RFK At FDA: “Dissidents Will Be Listened To,” HHS Secretary Kennedy Says; Commissioner Makary Calls For “More Teamwork,” Less “Individual Empires”
April 11, 2025
Prevision Policy Clips | FDA Animal Testing Alternatives “Roadmap” Sets Three-Year Agenda
April 11, 2025
FDA To Phase Out Animal Testing For Monoclonals, FDA Commissioner Makary Says; Pilot Test In 2025 Aims To Lead To Broader Changes As “NAM” Process Moves Forward
April 10, 2025
HHS Drug Shortage Policy Reset: Trump Administration Urged By GAO To Focus On Coordination At Department Level; Report Provides Update On FDA Activities As Of 2024
April 10, 2025
Prevision Policy Clips | GLP-1 Agonist Coverage In Medicaid/Medicare: “Regulatory Framework” Still Under Consideration
April 10, 2025
FDA Rare Disease “Hub” Is Moving Forward With Agenda To Improve Consistency And Coordination Amid Agency Changes
April 9, 2025
FDA Oversight Of Compounded GLP-1 Products Urged By Former Commissioner Kessler In House Hearing On “Illicit” Products
April 9, 2025
FDA Generics Office Urges Renewed Focus On Data Integrity At Annual Update Meeting; Speakers Demonstrate Commitment To GDUFA Goals Amid Restructuring
April 9, 2025
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