High Cost Drugs In Part D: MedPAC Report Highlights Call For New Reinsurance Formula

FDA’s Final Enrichment Strategies Guidance Adds Recent Examples And More Clarity On “Marker-Negative” Considerations

Prevision Policy Clips | Aimmune’s Peanut Allergy Drug On Slow Track At FDA

OCE Pediatric Cancer Advocacy Forum Showcases Strong Review Team

Clinical Trial Monitoring Plans Should Consider Workload, Turnover At Individual Sites, FDA Tells Sponsors In Q&A Update To Guidance

Generic Drug “Parking,” “Pay-For-Delay” Legislation Needs More Work, House E&C Hearing Witnesses Say

Prevision Policy Clips | CMS Updates Prescription Drug Pricing/Spending Dashboards

Drug Pricing Rule Check: Feedback From HHS Budget Hearings Suggest Rebate Elimination Rule Is Path Of Least Resistance; Part B Reg Coming

SMA Gene Therapy Reviewed By ICER: Is Any Price Too High?

Prevision Policy Clips | E&C Oversight & Investigations Drug Pricing Hearing Slated For April 11

Generic Drug-Focused Pricing Bills: CREATES, FAST Have Bipartisan Support But Await Tweaks; Other Bills Need More Work

Medicare Part D “Protected Classes” Proposed Rule Receives Bipartisan Criticism During E&C House Budget Hearing: Azar Taking Feedback “Seriously”

FDA Budget: Commissioner Gottlieb’s Parting Gift To Agency Is Request For Double Digit Increase In Appropriations Amid Cuts Elsewhere At HHS

Prevision Policy Clips | The Von Eschenbach Model: NCI’s Sharpless Is Acting FDA Commissioner

Oncology Trial Eligibility Guidances: Evidence In Adults Should Trigger Pediatric Patient Inclusion; Criteria Outlined For Five Under-Studied Populations

NCI’s Sharpless Is Acting FDA Commissioner; Oncology Background Aligns With Key FDA Regulatory Area, But Raises Issue Of Who Is Agency's Top Oncologist

NCI's Ned Sharpless Will Be Acting FDA Commissioner

Prevision Policy Clips | FDA Releases Five Cancer Trial Eligibility Guidances

Pharma Tax Deductions Are Expanding Target In Drug Pricing Hearings; IP Fixes Also Urged At Ways & Means/Health Hearing

HHS Budget Highlights Legislative Ideas For Drug Pricing; Co-Pay Cap And Medicaid Formulary Demo Among Repeat Ideas

Fleshing Out Binding Arbitration As Rx Launch Price-Setting Mechanism; MedPAC Proposal Worth Watching For Long Term Implications

Prevision Policy Clips | House Energy & Commerce/Health Drug Pricing Hearing March 13 To Focus on Generic, Biosimilar

Sanofi Dengvaxia May Test Companion Diagnostic Vaccine Model; Vaccine Likely Headed To Approval For School-Age Children With Prior Dengue Infection

Prevision Policy Clips | Amy Abernethy Won't Be Named Acting Commissioner of FDA

Senate Aging Drug Pricing Proposals Include Improving Transparency, Setting Out-Of-Pocket Caps; Hearing Witnesses Have Tough Words For Pharma