How Far Will Anti-China Sentiment Go? House Report Would Direct FDA To Refuse Data From China; Implementation Unlikely – But Message Is Still Significant

AI-Enabled “One-Day” Screening Pilot Launches With Focus On Low-Risk Facilities, FDA Commissioner Makary Says; IND Reforms Will Cut Unnecessary Information

Prevision Policy Clips | Cell & Gene Therapy CMC Flexibilities Guidance Urges Sponsors To “Leverage Prior Knowledge” In CMC Development, Justify Batches

“Quantitative Biopharmaceutics” Is The Future For “Innovative” Bioequivalence Determinations, FDA’s Lionberger Says; AI Makes New Approaches Feasible

FDA’s “Plausible Mechanism” Framework Is On A “Spectrum” Of Regulatory Flexibility For Ultra Rare Diseases; OTP Details Approach For Gene Edited Products

Prevision Policy Clips | Angelo De Claro Named Permanent Director Of FDA Oncology Center Of Excellence

AstraZeneca Crestor Switch Could Be Early Test Of “ACNU” Pathway At FDA; Sponsors Urge Acceptance Of Real-World Data, AI To Help Support Switch Applications

FDA Deadline Tracker: April Decisions Continue Mixed Messages About Regulatory Flexibility; CNPV Actions Are Changing Timelines

Prevision Policy Clips | Revolution Medicines’ Daraxonrasib Expanded Access Program Begins

PROs Fail To Save The Day Again: AZ Patient-Reported Outcome Data For Camizestrant Are Unpersuasive Of Efficacy, FDA Says; PRO Data For Truqap Make Safety Concerns Worse

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