Prevision Policy Clips | COVID Treatment Prices are "Reasonably Aligned" With Patient Benefit, Per ICER

FDA Pursuing More Partnerships On Artificial Intelligence; CDRH Director Shuren Says Contact With Collaborative Communities Will Be “Business As Usual”

Prevision Policy Clips | Single-Arm Trial For PI3K Inhibitor Zandelisib Not Sufficient For Accelerated Approval, FDA Tells Sponsors

Revamped Division Of Neurology 1, Peripheral & CNS Advisory Committee Under Spotlight For ALS Drug Review

Biosimilars User Fee Program “Working Well” And Growing, FDA Says; Teva Calls For Better Communication On Inspections

Prevision Policy Clips | China-Only Data Application For Lilly/Innovent’s Sintilimab Receives FDA Complete Response Letter

Prevision Policy Clips | FDA COVID Vaccine Efficacy Guidance Could Be Tested With Moderna EUA Request For Children Under Six

Prevision Policy Clips | CBER “Actively Working” On Office Of Vaccine Research & Review Leadership Vacancies, FDA Says

FDA Oncology Center Coordinates Safety Signal Assessments To Assure Consistency Across Drug Classes; “Project Protect” Featured In Annual Report

Prevision Policy Clips | COVID Booster Vaccine FDA Advisory Committee Set For April 6, But “No Vote” On Product-Specific Applications

FDA Hiring Process And Results Continue To Improve, External Assessment Indicates, But More Coordination Needed

Prevision Policy Clips | Oligonucleotide Therapeutics FDA Conference To Feature Principal Deputy Commissioner Janet Woodcock

Generic Drug, Manufacturing Reforms Have Some Industry Support As User Fee Ride-Alongs; Details Need Focus

PhRMA, BIO Hope To Fend Off Accelerated Approval Reforms, Diversity Mandates In User Fee Reauthorization; Legislative Tone Stays Positive In House Hearing

Parallel Scientific Advice: FDA Sees Greater Opportunity For Sponsors In Underutilized Program With EMA

Stuck In The Mud: Senate Drug Pricing Hearing Showcases A Stalemate, Though Wyden Presses For “Hardball Negotiation” In Medicare

Prevision Policy Clips | White House COVID Response Coordinator Will Be Brown’s Jha

CBER CAR T Research Looking To Decrease Immunogenicity; CBER’s OTAT Expects Internal Investigators To Apply Research To Regulatory Decisions

CAR T Product Development Guidance: FDA Recommendations Include Anticipating Manufacturing Changes, Early Assay Development

Prevision Policy Clips | FDA Continues To Meet Hiring Goals

Gene Editing Draft Guidance: FDA Recommends Staggered Enrollment With Children Last; “Clinically Meaningful” Primary Endpoint A Requirement

PREVENT Bill Mark-Up: FDA “Gold Standard” Extolled As Key Lesson Coming Out Of COVID; US Manufacturing Base Remains In Spotlight, LDT Reform Deferred

Prevision Policy Clips | FDA Gene Editing, CAR-T Draft Guidances Published March 15

Amyloidosis Public-Private Partnership With FDA Working on Multi-Domain Endpoints, Federated Data Analytics Approach

FDA Defends Accelerated Approval Follow-Up Process With Data; Is Low Withdrawal Rate A Sign Of A Different Problem?