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Clinical Trial Diversity: FDA’s Califf Wants Broader Conversation About Global Expectations, More Focus On Subsets – And Maybe Larger Trials
May 21, 2024
Prevision Policy Clips | OCE “Equity Program” To Be Co-Led By Division Of Hematologic Malignancies 2 Director Nicole Gormley, OCE Director For Regulatory Affairs And Policy Tamy Kim
May 21, 2024
Project Orbis Update: FDA Nearing 100 Approvals Under Global Oncology Collaboration; Japan, EMA And India Are Focus Of OCE Outreach Efforts
May 20, 2024
Prevision Policy Clips | Senate Judiciary Pharmaceutical Competition Hearing Will Include PhRMA VP Ulrich, Patient Advocate Mitchell
May 20, 2024
FDA Neurology Office “Very Open” To Accelerated Approval, Director Buracchio Says; CBER Officials See More Intermediate Endpoints For “Underutilized” AA Pathway
May 17, 2024
Prevision Policy Clips | Machine Learning For Shortage Prediction?
May 17, 2024
Rare Pediatric Disease PRV Reauthorization May Come With Strings Attached: New Authority For FDA To Mandate Pediatric Studies Of Orphan Drugs
May 16, 2024
Gene-Edited Cell Therapies Could Benefit From Early Use In Clinic, Researchers Argue; FDA Holding To Careful Characterization First
May 16, 2024
Prevision Policy Clips | BIOSECURE Act Passes House Committee On Oversight & Accountability
May 16, 2024
REMS “Logic Model” Is Next Step Towards Standardizing Risk Management Programs; FDA Outlines Framework As Part Of Effort To “Optimize” REMS
May 15, 2024
Prevision Policy Clips | House Committee To Mark Up Several FDA Bills, Including Potential Changes To Pediatric Cancer Research Program
May 15, 2024
More Is Not Always Better: OCE Foresees Shift To Three-Arm Trials To Measure Add-On Effect; Early-Stage Lung Cancer Is Just The Start, Pazdur Warns
May 14, 2024
BIOSECURE Act Sets 2032 Deadline For Severing Ties With A “Company Of Concern” Under Revised Draft, Five-Year Compliance Period Added For Newly Identified Firms
May 14, 2024
Prevision Policy Clips | Platform Technology Guidance Awaiting OMB Clearance
May 14, 2024
A Peek Inside OCE: FDA Oncology Division Directors See Advantages Of Keeping Sponsor Meetings Virtual, Reflect On Leadership Amid COVID
May 13, 2024
Prevision Policy Clips | Strategic National Stockpile “Mismanagement”: House E&C Republicans Issue Letter
May 13, 2024
CBER Is “Neutral” On CAR-T Manufacturing Strategies, So Long As Quality Is Maintained, Director Marks Says; “Wave” Of Automation Could Bring Down Costs
May 10, 2024
Prevision Policy Clips | Moderna RSV Vaccine Review Delayed By “Administrative Constraints”; FDA Will Miss Deadline
May 10, 2024
Senate Drug Shortage Bill Would Create Medicare Shortage Mitigation Program; Generic Medicaid Inflation Rebate Changes, Add-On Payments Included
May 9, 2024
Prevision Policy Clips | Duke Margolis Drug Shortage Prevention Workshop June 12
May 9, 2024
Advisory Committee Voting Still A Hot Topic: Sen. Manchin Pushes Califf To Keep Votes During Budget Hearing; Avian Flu Is Growing Priority For FDA And Congress
May 8, 2024
Prevision Policy Clips | Pfizer “Pauses” Dosing In DMD Gene Therapy Trial After Patient Death
May 8, 2024
CDER International Post-Market CMC Review Pilot Bearing Fruit, Director Cavazzoni Says; Single Review Platform For All CDER Apps Coming Soon
May 7, 2024
Making Medicare Price Cuts Work: CMS Proposes “Standard” Refund Tied To WAC, But Manufacturers Must Allow For Actual Cost Agreements; 340B Pricing Adds Complexity
May 7, 2024
Prevision Policy Clips | Lykos MDMA (Midomafetamine) Advisory Committee Review Will Test Climate For Psychedelic Treatments
May 7, 2024
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