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

Prevision Policy Clips | Makena Accelerated Approval Withdrawal Hearing To Take Place In September Or October 2022 And Will Be Virtual

ODAC On PI3Ks: Randomized Trials For All Future Products; FDA Says What It Means By Dose Optimization And Pazdur Gets Feisty On AA

Prevision Policy Clips | FDA Intends To Address Political Interference In Science Decisions

NTAP Class Of 2023: 13 Candidates Remain For Medicare Add-On Payment Status, But Only Four Have Cleared FDA; CMS Proposes To End COVID Extensions

Opioid “Mail-Back” Program Would Kick-Start Education On Proper Disposal, FDA Says In Floating New REMS Requirement; One Outcome Could Be Pharmacy Certification

Prevision Policy Clips | CDER, CBER Directors To Testify In Senate User Fee Hearing April 26

FDA Review Of PI3K Inhibitors Finds “Unprecedented Toxicity”: ODAC Aims To Rule Out Single-Arm Trials, Maximum Tolerated Dose Paradigm

Prevision Policy Clips | FDA Commissioner Califf To Testify On FDA Budget April 27

Advance Purchase Agreements May Be Left To Emergency Settings: Sponsors Tell ICER They Don’t See “De-Risking” R&D As Attractive Outside Of COVID Response

FDA Gene Therapy Advisory Committee Adds Two Virologists; Terms Extended To Create Core Of Six Members Through 2026

Prevision Policy Clips | Oncology Dose-Optimization Likely To Be Key Focus Of Scaled-Back ODAC

PI3K-Inhibitor Class Provides Backdrop For FDA Oncology Office To Push Dose-Optimization: Pre-ODAC Journal Article Outlines Issues; TG Pulls BLA

Prevision Policy Clips | TG Therapeutics Withdraws Ukoniq, Pending “U2” BLA Ahead Of ODAC Meeting

Prevision Policy Clips | FDA Finalizes Bioavailability Study Guidance

Moving Beyond Aduhelm: FDA/CMS “Parallel Conversation” On Post-Market Data Is Critical; Cell/Gene Therapy Is “Poster Child” For What Comes Next