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Prevision Policy Clips | Clinical Decision Support Software Draft Guidance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

Prevision Policy Clips | CBO Score of Pelosi Drug Pricing Bill By Mid-October

ICER Analysis Of Curative Therapies: Shared Savings Analysis Likely To Move Forward With Some Tweaks In November Final Report

FDA Wants Clinical Endpoints – Not Surrogates – In Alpha-1 Pre-Registration Studies, But Can Be Flexible On P-Values

Prevision Policy Clips | Amag Makena Accelerated Approval In Jeopardy? FDA Committee Will Discuss Failed Confirmatory Trial

Biosimilar Reimbursement Sweetener May Be Added To “Product-Hopping” Bill; House Hearing Features Testimony On Nuance Of Defining Anti-Competitive Conduct

House Part D Inflation Penalty Uses AMP, Rather Than Senate’s “WAC” Approach; HR3 Text Shows “Negotiation” Plan Is Even Worse Than It Sounds

“This Stuff Is Hard”: FOCR Real-World Evidence Collaboration Demonstrates The Promise – And Challenges – Ahead, FDA’s Abernethy Says

Prevision Policy Clips | Complex Innovative Trial Design Draft Guidance

House Unveils Rx Price Dictation Bill: Once-Unthinkable Policy Moves To Mainstream – But Big Difference Between Campaign Posture And Making Law

Beyond Price Negotiation: Key Items In House Bill Include $2,000 Out Of Pocket Cap In Part D, 10%/30% Mandatory Pharma Discounts

FDA Unveils Tech Revamp Championed By Deputy Commissioner Abernethy; Timelines Coincide With Key Funding Cycles

NDAC Recommends Approval Of GSK OTC Nicotine Spray With Trepidation Over Efficacy, Youth Abuse Potential

Prevision Policy Clips | House Drug Price Negotiation Bill: First Stop Will Be Energy & Commerce/Health Subcommittee