FDA Meeting Minutes Headline Changes In Sponsor/Agency PDUFA Meetings Guidance

Prevision Policy Clips | Eylea Biosimilar By Mylan/Momenta Headed To Clinical Trial Shortly

No Biomarker-Based Approvals For “Low T”: FDA Issues Draft Guidance Ahead Of Oral Testosterone Reviews

Spark Gene Therapy Pricing: Savvy Launch Strategy Hits All The Right Notes – But Will CMS See The Light?

FDA Advisory Committee Trends: Panels Voted “Yes” 79% of the Time In 2017

Prevision Policy Clips | HHS Secretary Nominee Azar’s Senate Confirmation Hearing Scheduled for January 9

Is The Drug Industry A Profit Outlier Or High-Return Sector Facing New Threats? GAO, NASEM Offer Different Data – But Broader Theme May Linger

Advisory Committee Tracker: Opioid Abuse Returns To Panel With A Twist – Two Attempts At “Better” Options

Prevision Policy Clips | FDA’s Big Year For Drug Approvals

Prevision Policy Clips | FDA Patient Affairs Staff is Operational; Andrea Furia-Helms is Director

Prevision Policy Clips | Medicaid Rebate “Misclassifications” Highlighted In IG Report

Prevision Policy Clips | Spark’s Luxturna Gets FDA Approval; Gene Therapy Drug Development Guidances Coming Soon

FDA Aims to Close Pediatric Orphan Drug Loophole, Will Stop Issuing Final Orphan Designations For Pediatric Subpopulations In Interim

Gene Therapy Drug Development Guidances Coming In “Early” 2018; Spark’s Luxturna “First Directly Administered Gene Therapy”

FDA Guidance On Patient Data Collection Methods To Be Released By June 2018; Agency Will Be “Flexible” On Accepting New Tools

Prevision Policy Clips | Orphan Drug Designations For Pediatric Subpopulations Fix

Prevision Policy Clips | Ultragenyx Sells PRV to Novartis for $130 Million

Refuse-to-File 1993 To Present: FDA Guidance Changed In Style, But Not Substance

Targeted Therapy Guidances From FDA Focus On Expanding Patient Populations and Accompanying IVDs

HHS Regulatory Agenda Is Heavy On FDA Rules; Drug Pricing Not On Priority List – Except For 340B Ceiling Price Revisions

Prevision Policy Clips | OMB Releases Fall 2017 Regulatory Agenda; HHS to Amend Final 340B Ceiling Price Rule

Opioid Attention Turns to Abuse-Deterrent Packaging: Same Challenges As ADFs – But Agency Considering Mandating Changes Via REMS Authority

Prevision Policy Clips | House Moving Slowly on Drug Costs; Attacks on Drug Industry Diluted By “Entire Panoply” of Supply Chain

House To Proceed Slowly On Drug Costs: PhRMA Benefits From Broad Focus Of First Health Subcommittee Hearing

FDA Releases Draft Guidance on Susceptibility Test Interpretive Criteria Labeling for Antibacterial and Antifungal Drugs