Prevision Policy Clips | Janssen COVID Vaccine Use Limited By FDA Due To Continued Blood Clot Risk

FTC Study On PBM Practices Is The Focus Of Senate Commerce Subcommittee Hearing

Clinical Trial Diversity Begins At Home? FDA’s Pazdur Wants More US Trial Sites; “Diversity Plans” Would Be Mandatory Under Bipartisan User Fee Law

Prevision Policy Clips | FDA User Fee Bill Unveiled; How Many FDA Reform Tracks Will There Be In 2023?

Bipartisan User Fee Reauthorization Bill Finds Common Ground On Accelerated Approval: Tweaks, Not Overhaul

FDA’s Case For Dose Optimization In Oncology: Slow Down In Phase I, Speed Up Overall Development; Will Sponsors Buy It?

Prevision Policy Clips | PBM “Black Box” Business Practices Is The Topic For Senate Commerce Subcommittee Hearing May 5

Advisory Committee Tracker: COVID Vaccines Take Center Stage, But “Appealing” Topics Loom As Well, From Acadia, Ardelyx and Makena

FDA Advisory Committee “Updating” Coming In 2023, Califf Says; Senior Agency Leaders Detail Top-Line Priorities On AA, User Fees And Importation

FDA “Liquid Biopsy” Draft Guidance Describes “Potential” For ctDNA As Early Endpoint—If Meta-Analyses Can Address Outstanding Issues

Prevision Policy Clips | Pfizer Expects Submission Of Three-Dose Pediatric COVID Vaccine EUA Request For Children Under In June 5

Crohn’s, Ulcerative Colitis Draft Guidances Recommend Endoscopic Measures Along With Symptom Scale; Tandem Guidances Cap Busy Period For FDA GI Team

Medicare Part D Pharmacy “DIR” Rule Finalized With 2024 Start Date; Broader Scope Means Bigger Savings For Rx Manufacturers Despite One-Year Delay

Prevision Policy Clips | Two More Chinese-Developed Oncology Drugs Rejected By FDA, But One Has Clear Path

Prevision Policy Clips | COVID Vaccine Reviews Planned For June Include Novavax EUA And Fall 2022 Strain Update

Commissioner Califf’s Return To Oversight Process Starts Smoothly In FDA Approps Hearing; “Data, People And Buildings” Is Key Message – Along With The Wisdom Of Experience

Part D Point-Of-Sale Rebate Final Rule To Be Issued “Very Soon,” HHS Secretary Becerra Tells House Committee

Prevision Policy Clips | Moderna EUA Request For COVID Vaccine In Children Under Six Will Be Complete “Next Week”

Prevision Policy Clips | House GOP “Healthy Future” Task Force Plans Series Of Rx Innovation Proposals

Alzheimer’s Pipeline Is “Robust,” CDER’s Cavazzoni Says During User Fee Hearing; Too Soon To Speculate On Impact Of CMS’ Aduhelm Decision

Prevision Policy Clips | FDA Foreign Inspections: Still No Clarity On Return To Normal

FDA Prepares For Multi-Cancer Screening Regulatory Reviews; Device Center Has Experience With RWD; OCE Interested In Impact On Drug Trials

Prevision Policy Clips | Ardelyx Appeal Of Tenapanor Rejection By FDA Will Go Before Advisory Committee

Makena AA Withdrawal Hearing: FDA Sets Scope, Format Of Discussions; RWE “Not Sufficient” To Confirm Benefit

ACIP Favors Annual Fall COVID Booster Program; Preventing Severe Outcomes Should Remain Primary Vaccination Goal