AstraZeneca Gets ODAC Win With Truqap sNDA In Prostate Cancer; Advisory Committee Says Modest PFS Benefit Outweighs “Manageable” Toxicities

Prevision Policy Clips | CBER Deputy Szarama Will Be Acting Center Director For Now

AstraZeneca Camizestrant ctDNA-Guided Breast Cancer Indication Fails At ODAC; First-Line Trial May Be Most Likely Path To Market

Prevision Policy Clips | FDA Proposes Not to Include Semaglutide, Tirzepatide and Liraglutide on 503B Bulks List

Advisory Committee Tracker: COVID Strain Selection Meeting Will Be Latest Test Of Vaccine Climate At FDA; Product Reviews Still MIA

Prevision Policy Clips | One Prasad Position Filled: Mallika Mundkur Is FDA’s Acting Chief Medical And Scientific Officer

FDA To Launch “Real-Time Clinical Trial” Pilot In August; Commissioner Highlights Amgen, AZ Studies As Proof Of Concept

AstraZeneca’s Truqap sNDA Will Face Uphill Battle At ODAC: Magnitude Of Clinical Benefit – Plus Fatal Toxicities – Will Make For Tough Review

GDUFA Negotiations Wrap Up After Agreement On New Fee Structure; “America First” Changes To Promote Onshoring Will Be Included

AZ ctDNA-Based Strategy Leaves FDA “Uncertain” About Camizestrant Efficacy Heading Into Advisory Committee; First ODAC Post-Pazdur May Test FDA’s Ability To Shape A Vote

Prevision Policy Clips | FDA Formally Moves To Withdraw Amgen’s Tavneos Citing “Untrue Statements Of Material Fact”

FDA Quality Management Maturity Program: Pilot Work Continues, Plans For Scale-Up TBD; 2024 Cohort Results Shared At Generic Drugs Forum

Prevision Policy Clips | Compass, Usona And Transcend/Otsuka Receive CNPVs For “Psychedelic” Medications

FDA Launching OTC Switch Pilot: Agency Will Identify Drugs To Make Nonprescription, Work With Sponsors On Applications; ACNU Pathway Has “Great Potential,” FDA’s Murry Says

Prevision Policy Clips | Regeneron DB-OTO Deafness Gene Therapy Will Be Free In US After FDA Approval April 23

Prevision Policy Clips | CMS Drug Price Negotiation Town Hall: Formulary Access, Utilization Management Are Focus

Office Of Generic Drugs Paints Rosy Picture Of Performance At Annual Forum: ANDA Rejections, RTRs Declining; “Q1/Q2” Advice Having Positive Impact

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