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Prevision Policy Clips | Patient Focused Drug Development “Methods” Draft Guidance
September 30, 2019
Opana IR Pediatric Use Studies Have Safety/Efficacy Concerns, Committee Says In Voting Against Inclusion In Labeling; Will FDA Follow Butrans Precedent?
September 27, 2019
ADFs For CNS Drugs: Existing Opioid Guidance Provides “Principles” For Other Classes; FDA Seeking Ideas To Address Stimulant Misuse Trend
September 27, 2019
Prevision Policy Clips | FY 2020 Priority Review Voucher User Fee Is $2.2 Mil.
September 27, 2019
FDA New Drug Review Office Reorganization Approved: Ongoing Reviews May Shift, But Team Will Stay Intact
September 26, 2019
Insulin May Be Next Target For “Netflix” Subscription Models; Lessons Learned From Washington State Experience in HCV
September 26, 2019
Prevision Policy Clips | Clinical Decision Support Software Draft Guidance
September 26, 2019
House Price “Negotiation” Hearing: All Roads Lead Back To Part D Overhaul; Will Dems Hold Out For Repeal Of “Non-Interference” Clause?
September 25, 2019
Prevision Policy Clips | Small Changes in Preliminary List of Approved NDAs for Biologics That Will Be Deemed to be BLAs
September 25, 2019
FDA “Project Orbis” Parallel Review Pilot Will Eventually Target “Major Impact” Oncology Applications, But OCE Is Starting With Easier Reviews
September 25, 2019
Complex Trial Design: Simulation Is Key Element For FDA, But No Stimulation Needed To Engage Agency
September 24, 2019
FDA Allowing Regulatory Flexibility In ALS Clinical Studies: Final Guidance Moves Away From Placebo-Controlled RCTs; Methods To Expedite Trials Encouraged
September 24, 2019
Sharpless Confirmed: Two Weeks Until Biopharma Congress
September 24, 2019
Prevision Policy Clips | CBO Score of Pelosi Drug Pricing Bill By Mid-October
September 24, 2019
ICER Analysis Of Curative Therapies: Shared Savings Analysis Likely To Move Forward With Some Tweaks In November Final Report
September 23, 2019
FDA Wants Clinical Endpoints – Not Surrogates – In Alpha-1 Pre-Registration Studies, But Can Be Flexible On P-Values
September 23, 2019
Prevision Policy Clips | Amag Makena Accelerated Approval In Jeopardy? FDA Committee Will Discuss Failed Confirmatory Trial
September 23, 2019
Biosimilar Reimbursement Sweetener May Be Added To “Product-Hopping” Bill; House Hearing Features Testimony On Nuance Of Defining Anti-Competitive Conduct
September 20, 2019
House Part D Inflation Penalty Uses AMP, Rather Than Senate’s “WAC” Approach; HR3 Text Shows “Negotiation” Plan Is Even Worse Than It Sounds
September 20, 2019
“This Stuff Is Hard”: FOCR Real-World Evidence Collaboration Demonstrates The Promise – And Challenges – Ahead, FDA’s Abernethy Says
September 20, 2019
Prevision Policy Clips | Complex Innovative Trial Design Draft Guidance
September 20, 2019
House Unveils Rx Price Dictation Bill: Once-Unthinkable Policy Moves To Mainstream – But Big Difference Between Campaign Posture And Making Law
September 19, 2019
Beyond Price Negotiation: Key Items In House Bill Include $2,000 Out Of Pocket Cap In Part D, 10%/30% Mandatory Pharma Discounts
September 19, 2019
FDA Unveils Tech Revamp Championed By Deputy Commissioner Abernethy; Timelines Coincide With Key Funding Cycles
September 19, 2019
NDAC Recommends Approval Of GSK OTC Nicotine Spray With Trepidation Over Efficacy, Youth Abuse Potential
September 19, 2019
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