Prevision Policy Clips | Prepping For PrEP To Move From D To B: CMS “Fact Sheet” Outlines Transition Process

CDER Trial Innovation Center (C3TI) Will Be “Central Hub” For Innovative Approaches, Including Pragmatic Trials; Former “Warp Speed” Chief Of Staff Bugin Will Lead Effort

Sickle Cell Gene Therapies Would Have Enhanced Payment For Inpatient Use Under CMS Proposal For FY 25; Six Other New Drugs/Biologics May Qualify For NTAP Class Of 2025

“Minimal Residual Disease” Is An Acceptable Accelerated Approval Endpoint In Multiple Myeloma, ODAC Says; FDA’s Withdrawal Authorities Make For Easy Vote

Prevision Policy Clips | “Point/Counterpoint” Advisory Committee Joint Documents Will Be “Default” For ODAC

FDA’s Case For Stronger Shortage Authority Pressed By Califf In Contentious House Oversight Hearing; Partisan Attacks Break With Recent Treatment Of Agency On Hill

Prevision Policy Clips | Sickle Cell Gene Therapies Are Bright Spot For Commissioner Califf

OGD Picking Up The Pace: ANDA Review Times Are Getting Faster, FDA Officials Tell Generic Drug Forum; GDUFA III Changes Are Helping

Prevision Policy Clips | Diversity Action Plans Guidance Heads To OMB For Review

“Minimal Residual Disease” Accelerated Approval Endpoint In Multiple Myeloma Supported By “Robust Data,” FDA Says Ahead of ODAC Meeting

Prevision Policy Clips | Xtandi Critics Try Another Long-Shot Price Cut Request: Letter To CMS

Prevision Policy Clips | 340B Program Office Has Permanent Head: Chantelle Britton

Prevision Policy Clips | J&J/Legend Carvykti Label Expansion Clears FDA; “Early Mortality” Warning

Prevision Policy Clips | FDA Commissioner Califf Will Testify At April 11 House Oversight Hearing: Drug Shortages, Inspections

HHS Considering “Manufacturer Resiliency Assessment Program” Based On Non-Governmental Accrediting Group As Part Of Shortage Response Plan

Prevision Policy Clips | Amylyx Withdrawing Relyvrio: Quick Closure Is Best Possible Outcome For FDA

The New Part D: CMS Finalizes 2025 Guidance For Plans; Formula For Specialty Tier Coinsurance Changes, But Range Remains 25%-33%

Prevision Policy Clips | Minimal Residual Disease Advisory Committee Discussion May Be “Highly Controversial”

FDA Urging Caution When Selecting BA/BE Testing Site Partners: Sponsors Should Confirm Quality Management Is In Place – And Report Fraudulent Behavior

Prevision Policy Clips | FDA Continues Focus On BA/BE Data Integrity With New Draft Guidance

Bioequivalence Test Sample Handling: FDA Warns Of “Concerning” Practices In Updated Guidance; Reduces Minimum Retention Amount Based On Newer Test Methods

Prevision Policy Clips | JAMA Cost-Based Pricing Analysis Of Antidiabetics Prompts Sen. Sanders To Call For Lower Wegovy Pricing

Clinical Trial Diversity: Pharma Firms Moving To Make Representative Trials “Business As Usual” – But Duke Event Stresses Gaps That Remain

Prevision Policy Clips | C-Path Launches DMD Clinical Trial Simulator

RTOR Tracker: FDA Oncology Real-Time Review Approval Pace Lags From 2021 Peak; First Known Rejection In 2024