CBER Urged To Devote More Effort To Cell & Gene Therapy Guidances To Share Approaches Discussed In One-on-One Sessions With Sponsors

Prevision Policy Clips | Medicare Weight Loss Demo: “GLP-1 Bridge” Will Run Through 2027, “BALANCE” On Hold

ANDA Application Fee Could Come Down Under GDUFA IV Proposals; Inspection Topics, “Data Fidelity” Dominate Recent Negotiations

Prevision Policy Clips | FDA Issues One-Year Progress Report On New Approach Methodologies To Reduce Animal Testing

PDUFA VIII Negotiations Run Behind Schedule, Meeting Minutes Indicate; Definition Of US-Based Company For Fee Waiver Still In Discussions

FDA, Industry Still Struggling To Define Threshold For Pediatric Gene Therapy Trials; Requirement For “Prospect Of Direct Benefit” Remains Key Challenge

Regulatory Flexibility Is “Consistent” For Ultra-Rare And Less Rare Diseases, FDA’s Rick Maintains; UniQure’s AMT-130 Receives Attention At NORD Meeting

FDA’s Summer Trip? Three CNPV Reviews Coming For Psychedelic Meds, Makary Says; Antidepressants Criticized At White House Event Promoting Psychedelic Therapies

Prevision Policy Clips | FDA To Issue Three CNPVs For Psychedelic Therapies “This Week”

“Plausible Mechanism” Framework Calls For Higher Data Quality Standards As Bespoke Therapies Move From Research To Approval, FDA’s Buracchio Says

Prevision Policy Clips | Kennedy Defends Replimune Rejection: “Marty Made The Correct Decision"

“Abbreviated BLA” Pathway Discussed At Senate HELP Hearing: MedPAC’s Miller Proposes Streamlined Biosimilar Requirements To Increase Competition

Prevision Policy Clips | FDA Planning Second Peptide Compounding Advisory Committee “Before The End Of February 2027”

CDER’s Innovative Trial Pilots Slow To Launch: Acceptance From Other Regulators Is One Reason, But Industry May Need To “Get Over” Risk Intolerance

ACT For ALS Reauthorization, Codification Of FDA Wearables Guidance Have Bipartisan Support In House; Is PAHPA Reauthorization Back On The Table?

Prevision Policy Clips | FDA “Single-Trial” Standard: “Burden Of Proof” Still On Sponsors

FDA Plays Hardball In GDUFA Negotiations: Threatens To Pull ANDA Priority Review Pilot; Finance Proposals Still Missing As Other Priorities Move Forward

CMS Takes Hard Line On NTAP Applications In Proposed Rule; Omeros’ Yartemlea Is Only Drug Agency Is Ready To Endorse For FY2027; Antibiotic Shortcut Pathway Would Be Eliminated

Gene-Editing “Off-Target” Effects: FDA Outlines Pre-Clinical Safety Testing Expectations In New Draft Guidance

Prevision Policy Clips | Lilly Foundayo Approval Letter Confirms January 20 Filing Date

FDA “PreCheck” Takes Shape: Agency Provides Additional Details On Domestic Manufacturing Facility Development Pilot

FDA, Industry March Toward PDUFA VIII Commitment Letter With Tweaks To Regulatory Decision-Making Proposals, Most Recent Meeting Minutes Show

Repeal And Replace Prior Authorization? Democratic Think Tank Proposes “Ban” On PA; CMS Wants To Add Drugs To Electronic PA Standards, Eyes Reforms To Step Therapy

Prevision Policy Clips | Replimune Rejected Again: New Review Team At FDA Is “Unanimous”

Prevision Policy Clips | CBER OTP Head Kumar Offers “Candid” Assessment Of Challenges With Pediatric Cell & Gene Therapy