Opioid Funding Formula Is Main Topic Of Latest “Cures” Hearing; Pharma Industry Emerges Nearly Unscathed

Prevision Policy Clips | GSK’s Nucala Gets Orphan Indication Approval For Treatment of Rare Autoimmune Disease

Senate Drug Pricing Hearing Series Wraps Up: Big Themes, But Legislators Still Thinking Small; Patent “Gaming” One Likely Focus Going Forward

FDA “Devices Referencing Drugs” Hearing Discusses Supplemental Label “Owned and Operated” By The Device Sponsor

Prevision Policy Clips | "Refuse to File: NDA and BLA Submissions to CDER" Draft Guidance

Interstitial Cystitis And Bladder Pain Syndrome: Broader Is Better For Clinical Development, Committee Says

Prevision Policy Clips | “Opioid Policy Steering Committee: Prescribing Intervention--Exploring a Strategy for Implementation” Hearing

The Need for Phase III: Multiple Myeloma Immunotherapy Combo Failure Highlights Importance of Late-Stage Randomized Trials

Prevision Policy Clips | FDA Finesses Capitol Hill Interest In Regenerative Medicine, Focusing on Gene Therapy, Editing

ICER Tardive Dyskinesia Meeting Features Indication-Based Pricing, Covering Neurocrine’s Ingrezza Or Teva’s Austedo—Not Both

Senate Health “Cures” Hearing: FDA Finesses Capitol Hill Interest In Regenerative Medicine By Focusing on Gene Therapy, Editing

Prevision Policy Clips | Digital Health/Software Guidances and Workshop Announced

FDA Shared Control Arm Proposal For Rare Pediatric Diseases Is Not New – But Still Important

Prevision Policy Clips | Rare Pediatric Disease Drug Development Draft Guidance

Prevision Policy Clips | Division of Metabolism & Endocrinology Director Guettier Leaving FDA for Private Sector

Division of Metabolism & Endocrinology Director Guettier Leaving FDA for Private Sector

Prevision Policy Clips | CVS Health to Acquire Aetna for $69 Billion

FDA-NCI Workshop On Adjuvant Trial Design In Bladder and Renal Cancer

House “21st Century Cures” Hearing Is Victory Lap For FDA And Innovators; Gottlieb Highlights New Clinical Trial Designs In Testimony

NASEM Drug Cost Report: Incremental Steps Dressed Up As Bold Action Should Align Well With HHS Agenda

Prevision Policy Clips | Indivior’s Sublocade, First Once-Monthly Buprenorphine Injection, Gets FDA Approval

FDA Streamlined Hiring Pilot Program To Begin Early Next Year; CDER Lags CBER In User Fee Hires So Far

Advisory Committee Tracker: FDA Re-Do Reviews Highlight Start Of 2018 – Oral Testosterones And Inhaled Ciprofloxacin

PFDD Guidance Development Underway: FDA’s Initial Focus Is On Methods To Collect Patient Input; Public Workshop Is December 18

Prevision Policy Clips | Aradigm’s Ciprofloxacin NDA to Advisory Committee January 11, 2018