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

July 18, 2025

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

July 18, 2025

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

July 18, 2025

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

July 18, 2025

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

July 17, 2025

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

July 17, 2025

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

July 16, 2025

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

July 16, 2025

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

July 15, 2025

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

July 15, 2025

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

July 14, 2025

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

July 14, 2025

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

July 13, 2025

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

July 11, 2025

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

July 11, 2025

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

July 10, 2025

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

July 10, 2025

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

July 10, 2025

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

July 9, 2025

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

July 9, 2025

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

July 8, 2025

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

July 8, 2025

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

July 8, 2025

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

July 8, 2025

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

July 7, 2025
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