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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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