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

FDA Wants “Diversity Plan” From All IND Holders By End-Of-Phase-II Meeting, And Preferably Earlier; Oncology “Project Equity” Leads To FDA-Wide Guidance

Prevision Policy Clips | Aduhelm Sets "No New Direction": CMS National Coverage Decisions For Drugs Will Remain “Rare Situation”

FDA Suggests “Enhancements” To Opioid Prescriber Education Blueprint While Debate Over Mandates, “Flexibility” Continues

Prevision Policy Clips | Aduhelm Coverage Details Still TBD: “We Look Forward To Seeing That Protocol,” CMS Says

Prevision Policy Clips | FDA Workshop On Antimicrobials For Uncomplicated UTI June 3