FDA Rare Disease Hub Gains Traction With $1 Million Budget For 2026; Agenda Includes PFDD Workshop And Plan For Rare Disease Staff Training

Prevision Policy Clips | HHS Expands Coverage Of Opioid Use Disorder Therapies

FDA Deadline Tracker: First Novel CNPV Approvals Coming In February? Warning Signs Abound For Other Applications

Advisory Committee Tracker: Still No Drug Panels Planned For 2026; “RISE” Meetings Are One Area Where FDA Public Engagement Continues

Prevision Policy Clips | FDA Pediatric Voucher Renewal, PBM Reforms On Cusp Of Enactment

Prevision Policy Clips | “Clear Labels Act” Would Require Country Of Origin Labeling For Pharmaceuticals

Achieve Smoking Cessation Treatment Cytisinicline Has FDA CNPV, But ICER Committee Sees Little Benefit Versus Chantix; Price Below $3,000 Per Year Could Be Cost Effective

Sanguine Sign At CBER: Grifols’ Blood Product Fesilty Approval Demonstrates Steady, On-Time Reviews Despite Upheaval In Center Management

Prevision Policy Clips | FDA Rare Disease Hub March 30 “RISE” Meeting Will Focus On Data Sharing

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