FDA Begins Pilot Test Of New Combination Product Review Procedures; Jump Start To Big Focus For PDUFA VI

FDA Sets September Committee Dates For Spectrum Bladder Cancer Drug And Pfizer Chantix Safety Review

Weekly Highlights: July 25-29

FDA Device Center Issues Guidance On Real-World Evidence, Adaptive Trials; Drug Center Commits To Catch Up In PDUFA VI

CMS Cardiac Bundle May Boost New Anticoagulants; Timely Reminder That Payment Reform Can Be Positive For Rx Industry

User Fee Math: Product Line Will Be Key Fee Component In PDUFA VI; Establishment, Supplement Fee To Be Eliminated

PDUFA VI “To-Do” List: FDA Has Long List of Deliverables Beyond Traditional Review Goals

Weekly Highlights: July 18-22

FDA Continues Proactive Approach To Antibacterial Development: Stepping In Early To Single-Species Area

Valeant Psoriasis Antibody Clears Committee Hurdle: Suicidality Can Be Managed Post-Approval, But No Agreement On How

PDUFA V “Program” Receives Plaudits With Few Changes In PDUFA VI; Efficiency Tweaks, Renewed Flexibility

PDUFA VI Agreement Policy Goals Match Review Goals In Length; Will They Support Or Supplant 21st Century Cures?

Weekly Highlights: July 11- 15

Valeant Psoriasis Antibody Faces Tough Panel Review: Multiple Safety Issues Lead To Multiple-Choice Vote, Likely Rejection

CMS Guidance On Value-Based Pricing Suggests “Medicaid-First” Approach: Supplemental Rebates Provide One Route

Sandoz Etanercept Gets Unanimous Vote From FDA Arthritis Committee: Praise For Understanding Of Biosimilar Pathway

340B Program Enters Period Of “Good Faith”: Mega-Guidance Delayed To December (Or Beyond), Audits Finding Fewer Issues

Amgen’s Adalimumab Biosimilar Wins Unanimous “Yes”; FDA Should Approve By Sept. 25

Sandoz Biosimilar to Enbrel On Smooth Run Thru FDA; July 13 Panel Should Not Present Any Hurdles For August Approval

Humira Biosimilar Preview: All Signs Point to Approval; Amgen Switches Roles To Challenge AbbVie Franchise

Weekly Highlights: July 5-8

FDA Compounding Guidances Define “Essentially A Copy” As Broad Protection For Approved Drugs; Daraprim Copy Fails Test

HHS Raises Buprenorphine Cap to 275 Ahead Of CARA Conference; Pfizer Settlement May Set Opioid Marketing Rules

FDA Advisory Committee Tracker: Bring On The Biosimilars – Humira and Enbrel Copies Highlight July Panel Agenda

FDA Compounding Committee Goes Against FDA on Two Substances, Role of Expanded Access Debated