Novartis Kymriah CAR-T: “First Gene Therapy” Approved By FDA Includes CMS Collaboration On Outcomes-Based Pricing

CDER Deputy Moscicki Leaves For PhRMA; Second Top Drug Center Official To Depart This Year

100% User Fees: Key Debate For PDUFA VII Teed Up By Trump

Prevision Policy Clips | Part B Demo Is Officially Dead

FDA Previews Regenerative Medicine Policy, Thresholds to Delineate Products That Will Require Clinical Trials

Prevision Policy Clips | Acorda Receives Refusal to File Letter from FDA for Parkinson’s NDA

GDUFA II User Fee Rates Set: ANDA Filing Fee Will More Than Double In 2018, While Facility Fee Shrinks Nearly 20%

Prevision Policy Clips | Gilead To Acquire Kite for $11.9 Billion

Prevision Policy Clips | Spark’s Ophthalmic Gene Therapy Product To Advisory Committee

CDER Will Set Agenda For Pre-Approval And Surveillance Inspections Under New Arrangement With ORA

FDA/Industry OTC Monograph Reform Agreement Would Encourage New Formulations; Congressional Action On User Fee Program Needed

Prevision Policy Clips | Roche’s Emicizumab BLA Granted Priority Review by FDA

Prevision Policy Clips | EU and US To Share Medical Inspection Reports Under New Confidentiality Commitment

CDER/Office of Regulatory Affairs Prepare To Meet User Fee Inspection Goals With New “Concept Of Operations”

Commissioner Gottlieb’s FDA Team Takes Shape: Sherman Staying As Principal Deputy Reinforces Sense Of Continuity

FDA Shows Interest in Drug Development for C3G Rare Kidney Disease; Trial Design Issues Highlighted At External PFDD Meeting

Prevision Policy Clips | PTC’s Ataluren NDA To Peripheral and Central Nervous System Advisory Committee Meeting

Prevision Policy Clips | Pediatric Advisory Committee to Discuss Rx Opioid Cough Products, Abilify and Keppra

DTC Advertising: FDA Signals A Scaled-Back Approach To Risk Information

Prevision Policy Clips | FDA Exploring Limiting Risks in DTC Advertising to Severe, Serious or Actionable

Delay, Delay, Delay: 340B Ceiling Price Final Rule Effective Date Proposed For July 2018; HHS Signals More Pro-Biopharma Rulemaking

Cardiac Rehab Demo Rescinded, Part B Drug Payment Model Still Breathing?

Prevision Policy Clips | Bayer’s Baycol Tablets Approval Withdrawal by FDA

Prevision Policy Clips | HHS Inspector General Work Plan Update

Opioid Emergency Designation Could Permit Manufacturer Contracts, Stockpiling To Increase Access To Naloxone