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Prevision Policy Clips | CMMI Director Brad Smith Is Former Anthem Exec
January 7, 2020
Prevision Policy Clips | FDA Pain And Addiction Division Leadership Transition: Sharon Hertz Retires
January 6, 2020
Advisory Committee Tracker: 2020 Kicks Off With Test Of Climate For More Opioid Formulations
January 3, 2020
Prevision Policy Clips | Intercept's Obeticholic Acid for NASH FDA Advisory Committee Slated After PDUFA Date
January 3, 2020
Prevision Policy Clips | Who Needs Gottlieb? FDA Clears 48 NMEs In 2019
January 2, 2020
Bridging Guidance For Combination Products From FDA Sets Five-Step Framework To Identify Information Gaps
December 31, 2019
CPAM Process For FDA Agreements On Combo Product Development Pathways Introduced By FDA; But Agency States Strong Preference For Existing Processes
December 31, 2019
“Individualized” Clinical Trial Endpoints, Estimand Framework Reflect FDA’s Increasing Flexibility On COAs – Agency Says At PFDD Guidance Meeting
December 20, 2019
AbbVie’s Rinvoq Gets Ambivalent Response From ICER Panel; Rebate Agreements, Step Therapy, Biosimilars Get Public Airing In Review Of JAK-Inhibitors For RA
December 20, 2019
Substantial Evidence Update Brings Two Decades Of Existing FDA Practices Into FDA Guidance: New Examples, Key Concepts But Not Big Policy Moves
December 20, 2019
Prevision Policy Clips | Opioid Acute Pain Guidelines: FDA Reviewing NASEM Framework
December 20, 2019
Stimulant Use Disorder Treatments: FDA Eager For Endpoints Beyond Abstinence; March PFDD Meeting May Provide Valuable Input
December 19, 2019
Epizyme Benefits From ODAC With Added Sarcoma Specialists; 11-0 Vote Accepts Single-Arm Trial; Pazdur Puts Sponsor On Notice For Confirmatory Trial
December 19, 2019
Prevision Policy Clips | A Pretty Substantial Update: FDA Draft Guidance On “Demonstrating Substantial Evidence of Effectiveness”
December 19, 2019
FDA Self-Importation Guidance: Re-Pricing Work Around Moving Faster Than Broader Rule; Should Some Drugs Be Given “Special” Consideration?
December 18, 2019
State-Sponsored Import Plans Take One Step Forward With HHS Proposed Rule: Onerous Approach Could Yet Sink Under Its Own Weight – Or In Litigation
December 18, 2019
Prevision Policy Clips | State-Sponsored Canadian Drug Import Plans Are One Step Closer
December 18, 2019
ODAC Surprisingly Tight For Keytruda In High Risk Bladder Cancer Due To Delay Of Surgery Risk; FDA “Point/Counterpoint” Briefing Document “A Keeper”
December 18, 2019
AstraZeneca’s Lynparza Approval In Pancreatic Cancer Based On PFS Looks Favorable Despite Close Committee Vote; sNDA Benefits From “Pazdur Moment”
December 17, 2019
FDA Cancer Drug Approval Standards: Criticisms About Being “Too Fast” Are Really About The Price, Pazdur Says
December 17, 2019
CMS New Technology Payment Candidates For 2021: First-in-Class Treatments, And Two FDA-Pending CAR-Ts Plead Their Cases At Town Hall
December 17, 2019
Drug Price Debate Ends With A Whimper In 2019: CREATES Ready To Move With Year-End Funding Bill – Everything Else Carries Over
December 17, 2019
Prevision Policy Clips | 2019 Drug Price Debate Ends With Whimper: REMS “Abuse” (CREATES Act) Is Only Significant Provision
December 17, 2019
Epizyme’s Oral Tazemetostat For Rare Sarcoma Earns FDA Praise For Biologically Rational Approach, But Evidence Of Efficacy Is Low
December 17, 2019
Adherence Label Claims May Be On Horizon: FDA Reflects On How Sponsors Could Win Claims For New Formulations, Device/Drug, Patient Programs
December 16, 2019
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