FDA Wants “Diversity Plan” From All IND Holders By End-Of-Phase-II Meeting, And Preferably Earlier; Oncology “Project Equity” Leads To FDA-Wide Guidance

Prevision Policy Clips | Aduhelm Sets "No New Direction": CMS National Coverage Decisions For Drugs Will Remain “Rare Situation”

FDA Suggests “Enhancements” To Opioid Prescriber Education Blueprint While Debate Over Mandates, “Flexibility” Continues

Prevision Policy Clips | Aduhelm Coverage Details Still TBD: “We Look Forward To Seeing That Protocol,” CMS Says

Prevision Policy Clips | FDA Workshop On Antimicrobials For Uncomplicated UTI June 3

Prevision Policy Clips | FDA Finalizes Updated ICH Guidance On Clinical Trials (E8)

CMS Sticks To Its Guns On Aduhelm And Accelerated Approval: All Beta-Amyloid Alzheimer’s Therapies Face CED, Although Full Approvals Have Easier Path

Part D Price Inflation Is Real, MedPAC Data Indicate In First Review Of Rebate Data: Part B Prices Are Immediate Focus – With Recommendations A Year Away

FDA’s COVID-19 Vaccine Priority Is (Another) Booster Dose This Fall; Advisory Committee Leans Toward Switch To Multi-Valent Product

Prevision Policy Clips | Project FrontRunner: Targeting Earlier Cancer Settings For Accelerated Approval

FDA Quality Management Maturity White Paper: Program Will Benefit Regulatory Flexibility For Postapproval Changes; Advisory Committee Planned This Year

Prevision Policy Clips | Novartis Accelerated Approval Of Alpelisib For Novel PROS Indication Based On RWE

Multi-Component Biomarkers Framework Discussion Begins; FDA Wants To Know How Biomarkers Are Developed, Not Just How They Perform

User Fee Reauthorization Kick Off In Senate: Dems Push Drug Pricing (Generic/Biosimilar) Topics In Opening Hearing– Not Accelerated Approval Reforms

Prevision Policy Clips | COVID Funding Bill Dedicates $5 Billion To Therapeutics

Advisory Committee Tracker: “U2” ODAC Review Highlights April Agenda; Another Milestone In Oncology Accelerated Approval And Safety Projects

COVID-19 Variant Vaccines Based On Manufacturing Data Only? FDA Committee Will Consider Whether Flu Process Could (Eventually) Provide A Guide

FDA Tech/Data Modernization Efforts Helped In Pandemic Inspection Response: COVID Fostered RWD Research Lab

CMS Guidance Asks Manufacturers To Make It Easy For States To Join Value-Based Pricing Agreements; Add “GNUPs” To List Of Medicaid Acronyms To Know

Prevision Policy Clips | NCI Leadership Change Coming Amid “Moonshot” Reboot And While NIH Director Search Continues

FDA’s Gene Therapies Advisory Committee: Bluebird Bio Reviews Could Mark Start Of More Product Reviews Ahead For CBER Panel

Prevision Policy Clips | Insulin Co-Pay Cap Passes The House: One-Year Delay In “Rebate Rule”

COVID Vaccine Sponsors Should Demonstrate “Super” Superiority Of Variant Vaccines To Primary Doses, FDA Says In Revised Guidance

Prevision Policy Clips | COVID Vaccine Development Guidance Revised By FDA To Expand Section On Targeting New Variants

Amylyx AMX0035 For ALS Likely Headed For FDA Rejection After Agency Wins Close “No” Vote In Tough Context