CDER “Biomarker Incubator” Initiative Launched: First Pilot Will Focus On Kidney Toxicity, FDA Asks for Data – And Potential Next Topics

Prevision Policy Clips | Acting Commissioner Diamantas Takes The Reins At FDA

Acting Commissioner Diamantas Likely To Run FDA Through Mid-Terms After Makary Exits; Management Uncertainty Reigns With CNPV Future In Doubt

FDA Final Pregnancy Safety Guidance Adds Expectations For Registry Feasibility Studies And Postpartum Monitoring

Prevision Policy Clips | CDER “Biomarker Incubator” Launched: First Pilot Will Seek Data On Markers Of Kidney Toxicity

FDA Drug Repurposing Initiative: RFI Seeks Candidates For New Indication Approvals, Asks For Input On Barriers To Off-Label Use, Ways FDA Can Help

One-Day Inspectional Assessments Could Generate 483s, But Do Not Replace Standard Inspections, FDA’s Miller Says; PreCheck Program Expansion in “Active Discussion”

AI Use At FDA: Senior Leaders Describe Rapid Adoption Across Centers; “HALO” Upgrade Will Help Aggregate Background Info For Reviewers

Prevision Policy Clips | Dead Man Walking? Makary Is Still Commissioner Despite A Week Of Headlines

Prevision Policy Clips | FDA Reviewing “About 150 Comments” On Plausible Mechanism

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