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RTOR Tracker: FDA Oncology Real-Time Review Approval Pace Lags From 2021 Peak; First Known Rejection In 2024
March 28, 2024
Prevision Policy Clips | Akebia Vadadustat Completes Comeback: FDA Approval For Anemia In Dialysis Patients
March 28, 2024
Prevision Policy Clips | Merck Winrevair (Sotatercept) Approval Opens Potential For Patient At-home Administration
March 27, 2024
Prevision Policy Clips | Part B Inflation Rebate List Shrinks To 41 Drugs
March 26, 2024
CDER “Quantitative Medicine” CoE Is Example Of Structural Change To Foster Regulatory Innovation; “Time To Stop The Pilots,” Director Cavazzoni Says
March 25, 2024
Advisory Committee Tracker: “Minimal Residual Disease” Endpoint In Multiple Myeloma Will Be Focus Of April ODAC; Application Reviews Still Lagging
March 25, 2024
Prevision Policy Clips | ODAC To Advise On Minimal Residual Disease Endpoints: April 12 Meeting
March 25, 2024
Another Chance For VALID? House Committee’s Negative Reaction To FDA’s Proposed Lab-Developed Test Rule May Reopen Talks On Legislative Reform
March 22, 2024
Prevision Policy Clips | Medicare Phosphate-Binder Bundling Plan Would Be Delayed Until 2027 Under Amended Bill That Passes House Energy & Commerce Committee
March 22, 2024
Medicare Part D Plans Can Cover Anti-Obesity Drugs With FDA-Approved CV Risk Reduction Indications; Prior Authorization “Can Be Employed”
March 22, 2024
RWE In Observational Studies: FDA Focuses On Data Sources, Early Planning And Getting The Basics Right In New Draft Guidance
March 21, 2024
Prevision Policy Clips | DoD Pharmaceutical Supply Chain Risks Report
March 21, 2024
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Prevision Policy Clips | RWE Draft Guidance On Observational Studies Underscores Importance Of Data Sources, FDA Says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
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