Acting CBER Director Szarama Emphasizes Stability For Staff; Says Sponsor Characterizations Of Late-Stage Development Advice Reversals Are Just “One Perspective”

FDA’s First Public CNPV Review Memo: Otarmeni Summary Basis Of Approval Provides Little Insight Into Novel Review Process

CBER Endorses “Non-Traditional” Approaches In CMC Development For Cell & Gene Therapies In Guidance Aimed At “Flexibilities” To Lower Burden On Sponsors

First-In-China Trials May Prove Counterproductive For Sponsors, OTP’s Kumar Says During FOCR Event; CMC Delays Remain Key Factor Slowing CAR-T Development

Prevision Policy Clips | FDA Commissioner Martin Makary Will Testify At May 13 Senate Appropriations

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