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

April 26, 2022

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

April 25, 2022

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

April 25, 2022

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

April 22, 2022

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

April 22, 2022

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

April 22, 2022

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

April 21, 2022

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

April 21, 2022

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

April 20, 2022

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

April 20, 2022

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

April 20, 2022

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

April 19, 2022

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

April 19, 2022

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

April 18, 2022

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

April 18, 2022

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

April 18, 2022

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

April 15, 2022

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

April 15, 2022

Prevision Policy Clips | FDA Finalizes Bioavailability Study Guidance

April 14, 2022

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

April 14, 2022

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

April 13, 2022

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

April 13, 2022

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

April 12, 2022

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

April 12, 2022

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

April 11, 2022
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