Prevision Policy Clips | Akebia Vadadustat Completes Comeback: FDA Approval For Anemia In Dialysis Patients

Prevision Policy Clips | Merck Winrevair (Sotatercept) Approval Opens Potential For Patient At-home Administration

Prevision Policy Clips | Part B Inflation Rebate List Shrinks To 41 Drugs

CDER “Quantitative Medicine” CoE Is Example Of Structural Change To Foster Regulatory Innovation; “Time To Stop The Pilots,” Director Cavazzoni Says

Advisory Committee Tracker: “Minimal Residual Disease” Endpoint In Multiple Myeloma Will Be Focus Of April ODAC; Application Reviews Still Lagging

Prevision Policy Clips | ODAC To Advise On Minimal Residual Disease Endpoints: April 12 Meeting

Another Chance For VALID? House Committee’s Negative Reaction To FDA’s Proposed Lab-Developed Test Rule May Reopen Talks On Legislative Reform

Prevision Policy Clips | Medicare Phosphate-Binder Bundling Plan Would Be Delayed Until 2027 Under Amended Bill That Passes House Energy & Commerce Committee

Medicare Part D Plans Can Cover Anti-Obesity Drugs With FDA-Approved CV Risk Reduction Indications; Prior Authorization “Can Be Employed”

RWE In Observational Studies: FDA Focuses On Data Sources, Early Planning And Getting The Basics Right In New Draft Guidance

Prevision Policy Clips | DoD Pharmaceutical Supply Chain Risks Report

Pazdur Interviews ODAC: Use Of Industry “Experts” Can Be Biased, Members Say, Point/Counterpoint Is Helpful – And The Approvability Vote Is Critical

Prevision Policy Clips | RWE Draft Guidance On Observational Studies Underscores Importance Of Data Sources, FDA Says

Prevision Policy Clips | FDA Proposes Three Drug Categories To Be Added To “Demonstrable Difficulties For Compounding” Lists

Bristol's Abecma Survives ODAC: CAR-T Supplemental Use In Multiple Myeloma Supported Despite Excess Early Deaths; “Yes” Votes Swayed by “Prolonged” PFS

Prevision Policy Clips | Biden EO On Women’s Health Includes Call For FDA Guidance On Inclusion In Clinical Trials

Carvykti Gets ODAC Unanimous Support For Move Up In Multiple Myeloma Treatment Line; “Front-Loaded Risk” Of Early Deaths Worth “Long-Tail” Benefits

FDA AI Paper Highlights Cross-Center Coordination: Message Affirms Preparation For Impact Of New Technology – With Details Still To Come

Prevision Policy Clips | Medicare Coverage For Anti-Obesity Agents, PBM Reform, TCET Finalization Receive Attention At Senate Finance Committee HHS Budget Hearing

Geron Imetelstat Wins ODAC Support In Face Of Tough FDA Review: Panel Showcases Pazdur’s Message About Better Discussions; OCE Director Does Not Intervene

Prevision Policy Clips | CBO Scores For Pay-For-Delay, Sham Citizen Petition Bills Released

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

Prevision Policy Clips | Medicare Phosphate-Binder Bundling Plan Would Be Delayed Until 2033 Under House Bill

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

Prevision Policy Clips | CAR-T ODAC Reviews: University Of Washington Hematologist Granted Waiver, FDA Posted