FDA Layoff Impact On Review Activities Detailed By CDER In Letter To Vanda; Message In Context Of Dispute May Have Broader Audience In Mind

Prevision Policy Clips | Novavax COVID BLA Review: Company Asked For Post-Marketing Commitment “To Generate Additional Clinical Data”

MASH Histology Assessment AI-Assisted Tool Approved In Europe; Biomarker’s Qualification Is Ongoing At FDA

Nanoscope Retinitis Pigmentosa Treatment Would Benefit From Value-Based Contracting, ICER Says; Panel Revisits Ophthalmic Gene Therapy Seven Years After Luxturna

Prevision Policy Clips | OCE Loses Two More: Associate Director For Biomarkers And Precision Oncology Reena Philip

Conditional Approval Pathway For Ultra-Rare Conditions Based On “Plausible Mechanism” Floated By FDA Commissioner Makary

Prevision Policy Clips | CMS Center For Medicare Director Is John Brooks

FDA Advisory Committee Industry Reps Sacrificed To “Radical Transparency”; Commissioner Makary Defends FDA Cuts In On-Line Interview

Prevision Policy Clips | No More Industry Reps: FDA Advisory Committees Will No Longer Have Company Executives

CAR-T Differences Debated Again In CMS Discussion Of NTAP Applicants For FY 2026; 13 Drugs Seek New Technology Add-On Payments

Prevision Policy Clips | HHS Draft Budget Proposal Protects User Fee “Triggers,” But Cuts FDA Appropriations

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

Prevision Policy Clips | Improving The IRA: Trump Drug Pricing Executive Order Includes Call To End “Pill Penalty”

Prevision Policy Clips | FTC Looking To Roll Back “Anti-Competitive Regulations”

Saving Part D: MedPAC Debates Ways To Make Stand-Alone Plans More Viable; Warns That Future Of Traditional Medicare May Be At Stake

Fixing Biosimilars: Stelara Will Be Test Of Price Negotiation Impact; FDA Cuts May Have Significant Adverse Effect At Tough Time For Sector

“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

Prevision Policy Clips | Digital Health Technologies In Clinical Trials: FDA Viewpoint Posted In JAMA

FDA “Five-Office” Reorg Proposal Criticized By Former Senior Officials; Regulatory Work Is Too Specialized For A “Big Team Of Generalists”

RFK At FDA: “Dissidents Will Be Listened To,” HHS Secretary Kennedy Says; Commissioner Makary Calls For “More Teamwork,” Less “Individual Empires”

Prevision Policy Clips | FDA Animal Testing Alternatives “Roadmap” Sets Three-Year Agenda

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

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

Prevision Policy Clips | GLP-1 Agonist Coverage In Medicaid/Medicare: “Regulatory Framework” Still Under Consideration

FDA Rare Disease “Hub” Is Moving Forward With Agenda To Improve Consistency And Coordination Amid Agency Changes