Rare Disease Innovation Hub October Kick-Off Meeting Will Solicit Input On “Specific” Policy Priorities, Engagement Practices; OCE To Be Involved

Prevision Policy Clips | FDA Rare Disease "Hub" Priorities Are The Focus Of Oct. 16 In-Person Workshop

FDA Digital Health Advisory Committee To Be Led By ACC’s Bhatt: Generative AI Use In Devices Will Be Focus Of Inaugural Meeting In November

Prevision Policy Clips | CMS Declines To Set Expiration Date On Coverage With Evidence Development

FDA AI Policy: “Clarity Will Foster Innovation,” CDER’s Cavazzoni Says; “Context Of Use” Will Be Key Consideration For Risk-Based Approach In Upcoming Guidance

Prevision Policy Clips | FDA Draft Guidance On Use Of AI In Drug/Biological Development “Coming Soon,”

Harris VP Pick Walz Pushed Drug Pricing Transparency Policies; Capping Insulin Co-Pays, PDAB Also On Minnesota Governor’s Progressive Agenda

Prevision Policy Clips | Lykos’ MDMA NDA: FDA Decision Watched By Bipartisan Group Of Senators

Zevra’s Arimoclomol Clears FDA Advisory Committee In Niemann-Pick; GeMDAC Endorses Small But Consistent Efficacy In Inaugural Meeting

Prevision Policy Clips | Adaptimmune Tecelra Accelerated Approval: Short Confirmatory Trial Plan

Medicare Inpatient Sickle Cell Gene Therapy Enhanced Payments Will Total Nearly $300 Million In Fiscal 2025, CMS Estimates; Six New Drugs Gain NTAP Status

Prevision Policy Clips | Medicare Negotiated Prices Will Be Announced “Soon,” CMS Deputy

Prevision Policy Clips | FDA India Office Director Greg Smith Will Oversee Key International Outpost

Zevra’s Arimoclomol Will Be Tough First Review For GeMDAC; FDA Still Has Reservations About Efficacy In Niemann-Pick – But Leaves Room For A “Yes”

Prevision Policy Clips | Merck Responds To FDA Concerns About “Peri-Operative” Trial Designs

User Fee Rates For FY 2025: PDUFA Fees Stay Relatively Stable; Big Increases In Filing Fees For ANDAs And Biosimilars

Prevision Policy Clips | Part D Premium Fluctuations Prompt CMS To Offer Additional Stabilization Measures For 2025

Advisory Committee Tracker: GeMDAC Inaugural Meeting Will Test Waters For Rare Disease Reviews In CDER; Adcomms Themselves Remain Very Rare At FDA

Prevision Policy Clips | Vertex Non-Opioid Suzetrigine For Acute Pain Will Be Reviewed By ICER At February 2025

AI For Real World Data Generation: FDA Highlights Risk-Based Approach To Adoption For Regulatory Applications

House PBM Reform Hearing Points To Renewed Legislative Push In 2025: “Busting Up” The Big Three Could Be A Theme

Prevision Policy Clips | HHS Acting Chief AI Officer Will Be Micky Tripathi

AZ Imfinzi On Track For Broad Label In Early-Stage Lung Cancer—But Door Is Closing For “Peri-Operative” Claims Without Bigger Trials

Prevision Policy Clips | ARPA-H Real World Data Request For Information

CDRH Director Transition Will Have Tarver Overseeing Early Implementation Of LDT Rule; Will Other Center Directors Leave In 2025?