Prevision Policy Clips | FDA Stakeholders Need To Advocate For Advisory Committees To Return “In Full Force”

CNPV Review Process: FDA Is Formalizing And Tweaking New Program; “Tumor Board”-Style Vote Is Advisory Only, Staff Manual Says – But Center Director Is The Decider

Prevision Policy Clips | PBM Reforms Clear The House; Insurer-Owned GPOs May Be Next Target

Too Many Meetings: PDUFA VIII Negotiations Focus On Balancing Sponsor Desire For Better Meetings With Scheduling Challenges; FDA Against Public Action Packages

Prevision Policy Clips | Health Insurers In The Hot Seat: Pair Of Hearings Likely To Feature Finger-Pointing

PBM Reforms Ready To Pass At Last? PBM De-Linking, Transparency Provisions Revived In Funding Bill; PRV Extension, Orphan Exclusivity Fix Included As Well

Prevision Policy Clips | Valneva Withdraws Ixchiq Chikungunya Vaccine

Multiple Myeloma Trials Can Use MRD Or Complete Response As Accelerated Approval Endpoints, But PFS/OS Needed As Follow-Up, Draft Guidance Says

OTC Switches Will Be Major FDA Focus In 2026: White House Embraces Strategy; Makary Outlines Permissive Approach In Media Appearances; Will GLP-1s Be Affected?

Prevision Policy Clips | CNPV Process Headlines Put FDA On Defensive: Mundkur Disclaims Sign-Off Authority

Part D Stabilization “Years Away,” MedPAC Is Told; Changes To Rx Assistance Programs, Increase In Direct-To-Patient Sales Also Have MedPAC Attention

Prevision Policy Clips | White House Again Asks Congress To Enact MFN Pricing, Says Deals Will Be “Grandfathered”

Prevision Policy Clips | Senate HELP Committee Working To Schedule Appearance With FDA Commissioner Makary

FDA/EMA AI Principles Reflect Prior Guidance, Emphasize Context Of Use, Risk-Based Performance Assessment

Fallen STAR: FDA “Split Real-Time Application Review” Pilot Has No Participants, Agency Cancels Planned Assessment; Will CNPV Model Take Over?

Prevision Policy Clips | Setting STAR: FDA “Split Real-Time Application Review” Pilot Has No Participants

Release The Review? FDA’s Thanh Hai Suggests Disclosure Of Full Memos For Rejected Products May Be More Useful Than CRLs Alone

Prevision Policy Clips | AbbVie Joins Industry Most Favored Nation Pricing Pledge

CBER Guidance Agenda Includes New Vaccine Documents As Prasad Readies To Formalize Policy Changes; “Plausible Mechanism” Guidance In The Works

Cell & Gene Therapy CMC “Flexibility” Highlighted By FDA; Another Informal Policy That Sounds Good To Sponsors – But Product Review Decisions Continue To Raise Doubts

Citizen Pazdur: Former FDA Oncology Chief Says He Has No Interest In Retirement, Starting To Plan Next Steps

FDA’s New RWE Approach: Device Guidance Checklist, Criteria On Reliability/Relevance Of Data Sources Are Likely To Be Adopted For Drugs/Biologics

Prevision Policy Clips | FDA Highlights Cell & Gene Therapy CMC “Flexibility” Ahead Of JP Morgan Conference

FDA Bayesian Statistics Guidance Stresses Need For Documentation To Support New Methods; Case Studies Include Oncology Platform Trials, CID Pilot Proposals

Prevision Policy Clips | FDA Bayesian Analysis Draft Guidance Released, Fulfilling PDUFA Commitment