CBER To Individually Assess Ongoing Cell And Gene Therapy Trials In Post-COVID “Salvage” Effort, Director Marks Says

Model-Informed Drug Development Has Growing Role For CAR-T, Gene Therapy/Gene-Edited Products In Predicting Immunogenicity

Oncology “Core PROs” Guidance Continues FDA Effort To Collect More Patient Perspective—But In Manageable Amounts And Useful Forms

Prevision Policy Clips | Drug Pricing Remains Secondary Theme In HHS Budget Hearings; Aduhelm Not An Issue

FDA Advisory Committees Getting Overhaul (Again): Open Public Hearing, Conflict Of Interest Restrictions Among Initial Targets

COVID Clinical Trial Flexibilities Reflect “Sea Change” In FDA Reviewer Approach To Innovative Practices, Office Of New Drug Policy’s Smith Tells BIO

Prevision Policy Clips | Cures 2.0 Discussion Draft Is Coming Out In “Next Few Days”

Prevision Policy Clips | FDA Advisory Committee Overhaul: CDER Seeks "Greater Consistency And Less Surprises"

Prevision Policy Clips | Gardasil, Shingrix Could Benefit From Legislative Interest In COVID Vaccine Response

Prevision Policy Clips | FDA’s Woodcock Receives Praise On Aduhelm Accelerated Approval During Senate Appropriations Hearing

Aduhelm’s “Unconscionable” Price Is New Hook For Wyden Pricing Push, But Momentum Is Away From HR 3

Biden Administration’s Drug Production Resilience Plan Is Built Around New Consortia: Job One Is Paring Back Number Of Essential Drugs

A Constitutional Convention For FDA? Next Commissioner Should Re-Think “Confederacy Of Centers” Structure, Oncology Chief Pazdur Urges

Prevision Policy Clips | Aducanumab As Medicare Money Saver? HHS Secretary Becerra Agrees With The Premise At Hill Hearing

Prevision Policy Interview: The Future of Accelerated Approval With OCE's Richard Pazdur

“Dangling” Accelerated Approvals: FDA’s Pazdur Believes Message Is Getting Through After ODAC

FDA Oncology Chief Pazdur Welcomes Aduhelm: Sees Opportunity To Broaden Conversation About Improving Accelerated Approval

Prevision Policy Clips | What Does Aducanumab Mean For Accelerated Approval? OCE’s Pazdur Hopes Debate Will Foster Conversation About “Tweaks”

Prevision Policy Clips | White House To Push Legislation On Pharmaceutical Supply Chain

Aducanumab Approval For Alzheimer’s: Milestone For FDA And Biogen Will Have Important Ripple Effects On Accelerated Approval, Advisory Committees And CDER Leadership

Prevision Policy Clips | Another Busy Friday: FDA Clears Two NMEs And New Weight Loss Claim, But Not Aducanumab (Yet)

Prevision Policy Clips | Senate Finance HHS Budget Hearing June 10

CMMI Will Wait On Congress Before Proposing New Drug Price Responses; Any New Part B Reform Will Differ From Trump "IPI" Plan, Director Fowler Says

Prevision Policy Clips | Former FDA Deputy Abernethy Joins Verily As President-Clinical Research Platforms

FDA ICH Guidances: Estimand Framework Development Recommendations, Postmarket Approval CMC Changes Among Range Of Issues Covered By Seven New Documents