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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C. Difficile Draft Guidance From CDER’s Anti-Infectives Division Combines Advice For Four Indications: Treatment, Reduction of Recurrence, Treatment/Recurrence; Prevention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Prevision Policy Clips | CDER Draft Guidance On Drugs For C. Diff Infection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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