FDA Differs From ICH On Thresholds For Topical Ophthalmic Impurity Identification, Qualification In Quality Considerations Draft Guidance

CMMI Accelerates Timeline For Gene Therapy Value-Based Contracting Model, But Says “Accelerated Approval” Demo May Take More Time In Update On Drug Pricing Plans

Prevision Policy Clips | CMMI Gene Therapy Model Could Begin Enrolling States In 2025; “Accelerated Approval” Demo Will Take More Time

FDA Office Of Immunology & Inflammation Enters New Era With Acting Director Nikolov, Rheumatology Division Replacement Is Ozlem Belen

“Omics” Science At FDA: Commissioner Califf Cautions Against Letting Human Nature Jeopardize Potential For Systems Biology To Transform Medicine

Prevision Policy Clips | FDA Office of Immunology & Inflammation Acting Director Is Nikolay Nikolov After Departure Of Julie Beitz

Prevision Policy Clips | Mirati Buyout By Bristol Follows ODAC KRAS Review

Pazdur’s Next Crusade: Improving Conduct During Open-Label Trials To Prevent Bias; Amgen Lumakras Will Likely Retain AA But Needs Another Confirmatory Trial

Prevision Policy Clips | Obesity Drugs Would Increase Federal Spending If Covered By Medicare, Semaglutide Likely To Be Selected For IRA Price Negotiation, CBO Says

FDA Commissioner Califf Suggests Working With Congress To Allow For “Plain Language” In Agency Communications To Counter Misinformation

US WorldMeds Eflornithine For Neuroblastoma On Track For Milestone Approval: “Robust” Externally Controlled Trial Is Just Strong Enough To Overcome FDA Panel’s Wariness About Precedent

Prevision Policy Clips | ODAC Endorses Potential Milestone Approval: US WorldMeds Eflornithine Neuroblastoma Efficacy Based On Externally-Controlled Trial

Prevision Policy Clips | FDA Stimulant Use Disorder Treatment Draft Guidance Acknowledges “A Number of Uncertainties”

FDA Concerns About “Systemic Bias” May Doom Amgen’s Lumakras AA Conversion; Unusual “Errata” Document Softens Tone Of Review Document

Prevision Policy Clips | Acrotech Overdue Confirmatory Trials For Folotyn And Beleodaq Will Be Focus Of ODAC Review

US WorldMeds Eflornithine For Neuroblastoma: FDA Review Showcases Model For Externally Controlled Trial To Support Efficacy, Tests “Single-Trial” Flexibility

“Warp Speed” For Rare Diseases: CMC Readiness Is Key Criteria For CDER/CBER START Program

Prevision Policy Clips | FDA Shutdown Averted—For Now; Continuing Resolution Includes Animal Drug User Fee Reauthorization

FDA Lab-Developed Testing Rule Takes Hard Line, Citing COVID Lessons: Four-Year Phase-In Of Device Requirements, With No “Grandfathering”; Congress, Industry Have Time To Respond

Prevision Policy Clips | FDA Lab-Developed Test Rule Proposes Four-Year Phase In Of Oversight, And No “Grandfathering”

BrainStorm’s NurOwn File-Over-Protest Effort For ALS Cell Therapy Fails After FDA Advisory Committee Votes BLA Down; Additional Phase 3 Trial Needed

Advisory Committee Tracker: Vertex/CRISPR Exa-Cel, Merck Gefapixant Safely Scheduled Ahead Of Any Shutdown Disruptions

CMS Gene/Cell Therapy Medicaid Model Announcement To Come In Early 2024

Prevision Policy Clips | Will FDA Lab-Developed Test Reg Beat The Shutdown? OMB Has Completed Review

Digital Pathology Use In Oncology Drug Development: Calls For FDA Guidance Raise Chicken-And-Egg Dilemma; Who Will Be “First Mover” To Test New Approaches?