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PFDD Methods Draft Guidance Advises Considerations For Special Patient Populations, Encourages “Exit Interviews” For Clinical Trials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Prevision Policy Clips | Patient Focused Drug Development “Methods” Draft Guidance

Opana IR Pediatric Use Studies Have Safety/Efficacy Concerns, Committee Says In Voting Against Inclusion In Labeling; Will FDA Follow Butrans Precedent?

ADFs For CNS Drugs: Existing Opioid Guidance Provides “Principles” For Other Classes; FDA Seeking Ideas To Address Stimulant Misuse Trend

Prevision Policy Clips | FY 2020 Priority Review Voucher User Fee Is $2.2 Mil.

FDA New Drug Review Office Reorganization Approved: Ongoing Reviews May Shift, But Team Will Stay Intact

Insulin May Be Next Target For “Netflix” Subscription Models; Lessons Learned From Washington State Experience in HCV

Prevision Policy Clips | Clinical Decision Support Software Draft Guidance

House Price “Negotiation” Hearing: All Roads Lead Back To Part D Overhaul; Will Dems Hold Out For Repeal Of “Non-Interference” Clause?

Prevision Policy Clips | Small Changes in Preliminary List of Approved NDAs for Biologics That Will Be Deemed to be BLAs

FDA “Project Orbis” Parallel Review Pilot Will Eventually Target “Major Impact” Oncology Applications, But OCE Is Starting With Easier Reviews

Complex Trial Design: Simulation Is Key Element For FDA, But No Stimulation Needed To Engage Agency

FDA Allowing Regulatory Flexibility In ALS Clinical Studies: Final Guidance Moves Away From Placebo-Controlled RCTs; Methods To Expedite Trials Encouraged

Sharpless Confirmed: Two Weeks Until Biopharma Congress