Shionogi Cefiderocol: “Real World” Study Backfires, Making Complicated UTI Drug A More Complicated Review For FDA And Committee; Will LPAD Path Help?

FDA “Uni-Review” Roll-Out: Psychiatric Division Is Among “Early Adopters”; Collaboration Is Key Theme For New OND

FDA Office Of New Drugs Reorg Getting Warm Welcome From Division Directors, But Hiring Will Be Significant Pressure Point

White House War On Guidances Expands: FDA Is Not Main Target, But May Feel Some Collateral Damage

Prevision Policy Clips | House Price Negotiation Hearings Will Continue With Ways & Means Committee Oct. 17

Anti-Kickback Statute Remains Barrier To Rx Value-Based Agreements; New Rules Do Have Some Secondary Impacts

Prevision Policy Clips | FDA’s Role In “N of 1” Trials: Woodcock And Marks Editorial In New England Journal of Medicine

OCE Stands Alone: No Immediate Future For Integration Of FDA Medical Product Centers

Biopharma Congress Takeaways: FDA Reorg Appears Smooth, But Enough Is Enough

Prevision Policy Clips | HHS Anti-Kickback NPRMs Out; Future Rulemaking May Look At Safe Harbors For Pharma Value-Based Contracting

Novartis Remediation Plan For AveXis Shows Effort To Avoid Disruptive Integration In Quality Control Can Be Counterproductive

Prevision Policy Clips | FDA Draft Guidance On “Authorized” Imports Sent To OMB

Prevision Policy Clips | NTAP Town Hall December 16-17

Insulin Re-Pricing Bill Would Give Products Protected Status In Medicare—But At A Cost; Alternative Model For Price “Negotiation”?

Prevision Policy Clips | Trump Medicare Advantage Executive Order Amounts To Very Little

Part D Overhaul: MedPAC Continues To Refine Proposal; Discussion Highlights Implementation Work If And When Legislation Passes

Prevision Policy Clips | Trump EO Appears Aimed At Driving Medicare Advantage Enrollment, “Protecting Medicare”

Impeachment and Drug Pricing: There Still Could Be A Window For Significant Rx Legislation

PFDD Methods Draft Guidance Advises Considerations For Special Patient Populations, Encourages “Exit Interviews” For Clinical Trials

Amarin Vascepa Label Extension: Bigger Population May Pose Issues For Payors Despite Favorable Value Assessment By ICER

Advisory Committee Tracker: Makena’s Future Will Be Debated After Failed Confirmatory Trial For Pre-Term Labor Drug

Prevision Policy Clips | Enzyme Replacement Therapy Nonclinical Assessments Final Guidance

Singulair Advisory Committee Review Serves As Case Study In How To Update Warnings When Regulatory Options Are Limited And Product Is Generic

Prevision Policy Clips | Biopharma Congress Less Than One Week Away

Prevision Policy Clips | Patient Focused Drug Development “Methods” Draft Guidance