Part B Update Rules: CMS Proposes “Guardrails” For Service Fees; Plans Acquisition Cost Survey That Could Lead To 340B Payment Cuts In 2027

Novel Combination Regimens In Oncology: FDA Outlines Cases Where Sponsors Can Use External Data Rather Than Traditional Factorial Trials

GSK Blenrep ODAC Turns Into Bad Dream: Reapproval Bid Based On DREAMM-7/8 Trials Voted Down Due To Dose Issues, Lack Of US Subjects

Prevision Policy Clips | CDER Director Selection Is “Close,” Commissioner Makary Says

Real-Time Release Of CRLs Is FDA’s Goal, Commissioner Makary, CBER Director Prasad Affirm; Makary Reiterates Prediction Of “Record Year” For Drug Approvals In 2025

Prevision Policy Clips | FDA Commissioner Makary’s Voucher Program Would Promote “Pet Projects”

Otsuka/Lundbeck Rexulti For PTSD: FDA Wants Committee Vote On Whether Single Trial Can Support Approval With Uncertain Supportive Evidence; Leaves Opening For “Yes” Vote

Prevision Policy Clips | Direct-To-Consumer Advertising Targeted In Vaccine Injury Hearing

GSK Blenrep Reapproval Request: FDA Remains Concerned About Ocular Toxicity And Dose Selection; Potential Split Decision On Two Proposed Indications From ODAC?

Prevision Policy Clips | 60 NMEs In 2025? Commissioner Makary Suggests FDA Will Approve “At Least 20%” More

PDUFA VIII: Commissioner Makary Suggests Lower Fees Could Be One Goal, CEO “Listening Tour” Starts Focus On Communication, Predictability

Prevision Policy Clips | Commissioner’s Voucher As Incentive For Price Reductions? FDA Commissioner Makary

GDUFA IV Gets Underway: Makary Highlights Supply Chain Improvements During Kick-Off Meeting; Industry Asks For Continued Focus On Complex Generics

Remote Regulatory Assessments: FDA Clarifies That “Mandatory” RRAs May Still Include “Voluntary” Requests In Final Q&A Guidance

Prevision Policy Clips | Senate Appropriators Advance Flat FDA Funding For FY 2026: Improvement On House Version

FDA Posts Past Rejection Letters To Centralized Database For Approved Products; Non-Disclosure Policy For Unapproved Applications Remains In Place

FDA Pediatric Advisory Committee Member’s Call For Enhanced Monitoring Of Adverse Event Reports May Resonate With New Leadership

Prevision Policy Clips | FDA Makes Access To Already Public Rejection Letters Easier

Myelodysplastic Syndrome: FDA Affirms Viability Of Transfusion Independence As Efficacy Endpoint; Guidance Is First New Drug Development Advice Of Makary/Trump Era

Prevision Policy Clips | Senate FDA Appropriations Mark-Up Set For July 10

Reducing Animal Testing: New Biologics Pathway Modeled On 505(b)(2) Could Help, FDA Staff Tell Commissioner; Workshop Follows “Roadmap” On Alternatives To Animal Testing

FDA AI “Opt-In”? Agency May Ask Sponsors For Permission To Train AI Models Using NDA/BLA Data; Alternatives To Animal Testing Could Be Test Case

RTOR Tracker: FDA “Real Time” Review Use Picked Up In 2024 As Interest In Expansion Outside Oncology Increases

Prevision Policy Clips | Ending Animal Testing: FDA May Ask Sponsors For Permission To Train AI

Prevision Policy Clips | HR 1 Signed Into Law: Orphan Drug “Negotiation” Exemption Expanded, But Long Term Impact On Insurance Coverage