Prevision Policy Clips | Nektar Withdraws Oxycodegol NDA Hours After Unanimous "No" From FDA Advisory Committee

Durect’s Posimir: Contentious Regulatory History Casts Shadow Over Bupivacaine Formulation Heading Into FDA Committee Review

Prevision Policy Clips | FDA Office Of New Drugs Reorg “Phase III” Pushed One Week To January 21

IPC’s Aximris XR Oxycodone FDA Advisory Committee: Is Intravenous Abuse Deterrence Alone Enough To Support Opioid Approval?

Part D Billion Dollar Club In 2018 Comprised 30 Products Representing One-Third Of Program: CMS Dashboard Data Suggests Impact Of Inflation Rebates

Esteve Tramadol/Celecoxib Heads To FDA Committee With Straightforward Case For Approval – If Panel Is Willing To Approve New Opioid Combo

Prevision Policy Clips | FDA Biomarker “Concepts and Terminology” Workshop March 23

Nektar Oxycodegol Re-Starts Opioid Reviews: FDA Makes Case For More Approvals – But Not Necessarily This NDA; Single Efficacy Trial Could Be Hurdle

Prevision Policy Clips | Blueprint Medicines’ Ayvakit Is First NME Approval Of 2020

Prevision Policy Clips | CDER Director Janet Woodcock To Advocate For "Smart, More Inclusive" Drug Development

Prevision Policy Clips | Two Decades Of Progress On Cancer Mortality: New Treatments Key To Further Advances

FDA Advisory Committee Trends: Panels Voted “Yes” 78% of the Time In 2019; Selective Use For NMEs Continues

Prevision Policy Clips | CMMI Director Brad Smith Is Former Anthem Exec

Prevision Policy Clips | FDA Pain And Addiction Division Leadership Transition: Sharon Hertz Retires

Advisory Committee Tracker: 2020 Kicks Off With Test Of Climate For More Opioid Formulations

Prevision Policy Clips | Intercept's Obeticholic Acid for NASH FDA Advisory Committee Slated After PDUFA Date

Prevision Policy Clips | Who Needs Gottlieb? FDA Clears 48 NMEs In 2019

Bridging Guidance For Combination Products From FDA Sets Five-Step Framework To Identify Information Gaps

CPAM Process For FDA Agreements On Combo Product Development Pathways Introduced By FDA; But Agency States Strong Preference For Existing Processes

“Individualized” Clinical Trial Endpoints, Estimand Framework Reflect FDA’s Increasing Flexibility On COAs – Agency Says At PFDD Guidance Meeting

AbbVie’s Rinvoq Gets Ambivalent Response From ICER Panel; Rebate Agreements, Step Therapy, Biosimilars Get Public Airing In Review Of JAK-Inhibitors For RA

Substantial Evidence Update Brings Two Decades Of Existing FDA Practices Into FDA Guidance: New Examples, Key Concepts But Not Big Policy Moves

Prevision Policy Clips | Opioid Acute Pain Guidelines: FDA Reviewing NASEM Framework

Stimulant Use Disorder Treatments: FDA Eager For Endpoints Beyond Abstinence; March PFDD Meeting May Provide Valuable Input

Epizyme Benefits From ODAC With Added Sarcoma Specialists; 11-0 Vote Accepts Single-Arm Trial; Pazdur Puts Sponsor On Notice For Confirmatory Trial