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Pazdur Interviews ODAC: Use Of Industry “Experts” Can Be Biased, Members Say, Point/Counterpoint Is Helpful – And The Approvability Vote Is Critical
March 20, 2024
Prevision Policy Clips | RWE Draft Guidance On Observational Studies Underscores Importance Of Data Sources, FDA Says
March 20, 2024
Prevision Policy Clips | FDA Proposes Three Drug Categories To Be Added To “Demonstrable Difficulties For Compounding” Lists
March 19, 2024
Bristol's Abecma Survives ODAC: CAR-T Supplemental Use In Multiple Myeloma Supported Despite Excess Early Deaths; “Yes” Votes Swayed by “Prolonged” PFS
March 18, 2024
Prevision Policy Clips | Biden EO On Women’s Health Includes Call For FDA Guidance On Inclusion In Clinical Trials
March 18, 2024
Carvykti Gets ODAC Unanimous Support For Move Up In Multiple Myeloma Treatment Line; “Front-Loaded Risk” Of Early Deaths Worth “Long-Tail” Benefits
March 15, 2024
FDA AI Paper Highlights Cross-Center Coordination: Message Affirms Preparation For Impact Of New Technology – With Details Still To Come
March 15, 2024
Prevision Policy Clips | Medicare Coverage For Anti-Obesity Agents, PBM Reform, TCET Finalization Receive Attention At Senate Finance Committee HHS Budget Hearing
March 15, 2024
Geron Imetelstat Wins ODAC Support In Face Of Tough FDA Review: Panel Showcases Pazdur’s Message About Better Discussions; OCE Director Does Not Intervene
March 14, 2024
Prevision Policy Clips | CBO Scores For Pay-For-Delay, Sham Citizen Petition Bills Released
March 14, 2024
ODAC CAR-T Reviews: “Excess Early Deaths” At Issue For J&J’s Carvykti And BMS’ Abecma sBLAs; FDA Appears More Concerned With The Latter
March 13, 2024
Prevision Policy Clips | Medicare Phosphate-Binder Bundling Plan Would Be Delayed Until 2033 Under House Bill
March 13, 2024
Geron Imetelstat NDA Faces Tough FDA Review At ODAC; Transfusion Avoidance Efficacy Established – But Lack Of Other Benefits And Safety Risks May Doom MDS Application
March 12, 2024
Prevision Policy Clips | CAR-T ODAC Reviews: University Of Washington Hematologist Granted Waiver, FDA Posted
March 12, 2024
White House Budget Endorses “All-Interchangeable” Biosimilar Policy; FDA Seeks Modest Increase Despite Flat Funding In FY 2024
March 11, 2024
Early Alzheimer’s Drug Development Guidance Updated To Reflect FDA Expectations For Biomarker-Based Strategies—And Reality Of Accelerated Approvals
March 11, 2024
Prevision Policy Clips | Alzheimer’s Drug Development Draft Guidance Updated By FDA To Reflect “Current Thinking Regarding The Use Of Biomarkers"
March 11, 2024
FDA Promises Flexibility In Informed Consent Draft Guidance; Consults With Patient Advocacy Groups May Make Documents More Understandable
March 8, 2024
CMS Sickle Cell Gene Therapy Model RFA Includes ASP Waiver; PROs Among Four Outcome Metrics For Rebate Purposes Identified By CMMI
March 8, 2024
Prevision Policy Clips | Lilly’s Donanemab For Alzheimer’s Will Go To FDA Advisory Committee, Delaying Approvability Action
March 8, 2024
Complex Innovative Design Program Gets High Marks For “Informal” Collaboration With FDA, Agency Openness To External Controls
March 7, 2024
Prevision Policy Clips | Out-Of-Pocket Drug Spending Cap “For All” Is Big Positive For Biopharma, IRA Price Negotiation Expansion To “At Least” 50 Drugs Per Year Is Not
March 7, 2024
Janet Woodcock’s Exit Interview: Accelerated Approval “Differential Pricing” Models Could Encourage Confirmatory Trials, But Sponsors’ Financial Health Should Be Considered
March 6, 2024
Prevision Policy Clips | Lumicell’s Lumisight Breast Cancer Imaging Agent Clears FDA Advisory Committee With 16-2 Vote
March 6, 2024
Prevision Policy Clips | Vanda Hetlioz Jet Lag Indication Laid To Rest? FDA Denies Another Request
March 5, 2024
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