FDA Updated Expanded Access Q&A Guidance Emphasizes Safeguards And Sponsor Role; Reminds Patients FDA May Know More About A Drug Than Individual Physicians

Prevision Policy Clips | FDA Revises Expanded Access Q&A Guidance

C. Difficile Draft Guidance From CDER’s Anti-Infectives Division Combines Advice For Four Indications: Treatment, Reduction of Recurrence, Treatment/Recurrence; Prevention

Y-mAbs’ Omburtamab For Neuroblastoma Rejected By ODAC; FDA Concerns About External Control, Absence Of Response Rate Sway The Committee

Prevision Policy Clips | FDA Updates HCT/P Small Entity Compliance Guide

Expedited CMC Pilot Launched By FDA: Agency Wants “Diverse” Set Of Applications, With Initial Focus On Complex Biologics

Prevision Policy Clips | CDER Office Of Compliance Deputy Furman Will Serve As Acting Director

Advisory Committee Tracker: FDA Thins Out The Calendar With Four Meeting Cancellations; Cytokinetics Heart Failure Drug Set For December Review

GSK Daprodustat Wins FDA Committee Support For Use In Dialysis Patients Only; FDA Faces Decision About How To Weigh Other HIF-PH Data On CV Risks

Prevision Policy Clips | CDER Draft Guidance On Drugs For C. Diff Infection

Not All “Dangling” Accelerated Approvals Have To Go, FDA Explains In Response To Failed Confirmatory Trial For Jazz’ Zepzelca For Lung Cancer

Y-mAbs Omburtamab Neuroblastoma Survival Benefit Questioned By FDA Heading Into AdComm; Sponsor Hopes To Recover From RTF: Is ODAC Tired Of Saying “No” To Everything?

Prevision Policy Clips | FDA Advisory Committee Calendar Thins Out: Landmark OTC Contraceptive Review Among Four Fall Meetings Cancelled

Prevision Policy Clips | Pharmacy Compounding: FDA Will Not Enforce 5% Limit On Interstate Shipment

GSK Daprodustat Cardio Risk Versus ESAs Will Be Focus Of Advisory Committee Discussion; Safety Issues Mirror AstraZeneca’s Failed Roxadustat

Prevision Policy Clips | Makena Withdrawal Hearing Provides Fuel For Thought On Accelerated Approval Reform

CBER Status Report: Cell/Gene Therapy And Blood Products Work Getting Back “Toward Normal,” But Pandemic Strain Still Heavy On Vaccines, Director Marks Says

Prevision Policy Clips | Neurodegenerative Gene Therapy Development Final Guidance Has Few Changes

Novartis’ Alpelisib Rare Disease Indication Is An Early Milestone For RWE: FDA Describes Accelerated Approval Helped By Expanded Access

Makena Withdrawal Vote Underscores Accelerated Approval Integrity, But Process Suggests Fighting FDA Can Pay Off For Some Sponsors

Prevision Policy Clips | FDA Finalizes Multi-Endpoints Guidance

CDER ARC Rare Disease Program Takes Shape; CBER Plans “Warp Speed”-Style Pilot In “Coming Year”

White House Biodefense Strategy Update Sees Limited Role For FDA But Ambitious Goals For Developing Vaccines And Therapeutics In Future Pandemics

FDA “Advancing Real-World Evidence” Program Offers Early Feedback On RWE Plans To Support New Indications; Disclosure Agreement Is Required

Cancer Immunotherapy Sponsors Should Prospectively Assess Immune-Mediated Reactions In Clinical Trials, FDA Says; Broad Net Needed To Catch Adverse Events