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

November 1, 2022

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

November 1, 2022

C. Difficile Draft Guidance From CDER’s Anti-Infectives Division Combines Advice For Four Indications: Treatment, Reduction of Recurrence, Treatment/Recurrence; Prevention

October 31, 2022

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

October 31, 2022

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

October 31, 2022

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

October 28, 2022

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

October 28, 2022

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

October 27, 2022

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

October 27, 2022

Prevision Policy Clips | CDER Draft Guidance On Drugs For C. Diff Infection

October 27, 2022

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

October 26, 2022

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?

October 26, 2022

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

October 26, 2022

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

October 25, 2022

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

October 24, 2022

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

October 24, 2022

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

October 21, 2022

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

October 21, 2022

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

October 20, 2022

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

October 20, 2022

Prevision Policy Clips | FDA Finalizes Multi-Endpoints Guidance

October 20, 2022

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

October 19, 2022

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

October 19, 2022

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

October 19, 2022

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

October 19, 2022
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