Prevision Policy Clips | House Energy & Commerce Chair Pallone Says Committee Will Not Miss User Fee Program Reauthorizations Deadine

Supreme Court Likely To Rule Against HHS On 340B Payment Cuts, Broad Agency Deference To Stay Intact, Legal Experts Say At Brookings Event

Prevision Policy Clips | US Rx Spending Growth Expected To Normalize At About 5% Annually

FDA Accelerated Approval Reforms Included In Budget Proposal: Confirmatory Trial Plan Feasibility Test Needed For Approval, Withdrawal Procedures Simpler

Amylyx AMX0035 For ALS: FDA “Unpersuaded” By Current Dataset, Including Overall Survival Data; Committee Will Be Asked To Back Agency Versus Strong Patient Support

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