TrumpRx Ready For Takeoff? HHS OIG Tentatively Clears Runway For DTC Drug Sales Via New Advisory Opinion; RFI Suggests Many Unanswered Questions

Medicare Price Negotiation Class Of 2028 Unveiled: Top Part B Products Will Not Face Cuts In This Cycle; Novartis, Lilly Have Multiple Products Selected

Prevision Policy Clips | Medicare Price Negotiation Class Of 2028 Unveiled: Novartis, Lilly Have Multiple Products

Patient-Focused Drug Development Sessions In FDA Review Documents: Fiscal 2025 Was Landmark Year As PFDD References Steadily Increase

FDA Proposes “Per ANDA Program Fee” Under GDUFA IV To Reduce Impact of Generic Product Ownership Transfers; Onshoring Proposals Still In Play

“Buy American” Rx Incentives Proposed By CMS: Hospitals Committing To Domestic Purchasing For Essential Meds Would Receive Separate Payment, Special Designation

Prevision Policy Clips | CDER Deputy Director For Regulatory Programs Is Longtime OGD Official Sarah Ibrahim

Expanded Access At FDA: Compassionate Use “Not Affected” By Trump Policies Given Deep Knowledge Base At Agency, Former OCE Director Pazdur Says

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Myeloma Trials Can Use MRD Or Complete Response As Accelerated Approval Endpoints, But PFS/OS Needed As Follow-Up, Draft Guidance Says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