Prevision Policy Clips | CDER’s Accelerating Rare Disease Cures (ARC) Program Will Coordinate Development Of Policy

CBER Cell/Gene Therapy Enhanced Communication Pilot Program Floated As Way To (Eventually) Justify Funding For Additional Staff

FDA Inspection Backlog Could Be Greatly Eased By User Fee Bill Provisions; Foreign Manufacturer Focus Carries Forward In Bipartisan House Bill

FDA Oncology Dose Optimization Guidance Is Coming – But No Timeline Ready; Key Features Of Acceptable Dose Studies Suggested At FDA-ASCO Workshop

Prevision Policy Clips | House FDA User Fee Bill Mark-Up Set For May 11; ARPA-H Act Also On Agenda

Product Quality In Approval Decisions: FDA Outlines “Rare Circumstances” Where Quality Issues Can Be Resolved Post-Approval; “QPA” Is New Regulatory Lingo

Drug Pricing, R&D Incentives Relegated To Odds And Ends In Bipartisan FDA User Fee Reauthorization Bill

Prevision Policy Clips | COVID Vaccine 50% Efficacy Standard No Longer Applies—At Least In Pediatric Indications

FDA Rare Disease Reforms In User Fee Bill Are Minimal: Studies And Reports, Not New Center; Endpoint Advancement Pilot Would Be Codified

RWE Agenda At FDA Would Add Focus On EUAs Under Bipartisan User Fee Bill; Nudges FDA On Use For Accelerated Approval Trials

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FDA “Liquid Biopsy” Draft Guidance Describes “Potential” For ctDNA As Early Endpoint—If Meta-Analyses Can Address Outstanding Issues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