Precision Medicine Initiative Summit Calls for Patient Input; Obama Mentions FDA “Centers of Excellence” Model

FDA Advisory Committee Tracker: Trio Of “Breakthroughs” On Spring Agenda; Acadia Up First; Intercept, Clovis Follow In April

FDA House Approps Hearing: Generic Labeling, Cancer Moonshot; Ostroff’s First and Last as Acting Commissioner

FDA’s Role and Compassionate Use: Senate Homeland Security Hearing Features Old Questions In New Context

FDA Issues Two Refuse-To-Files In One Week: Coincidence, Or Pattern?

HHS Wants To Exert “Downward Pressure” On Drug Prices: Big Steps Would Take Legislation That Is Not Likely

340B Program Update: Waiting For Final “Mega-Guidance”; The Calm Before The Storm?

Promotion Issues Discussed at Sen Finance Opioid Hearing; Support for Part D Lock-Ins, Dems Want $600M Emergency Fund

CMS Transparency Strategy Advances: Part D Call Letter Links Up With Medicare Drug Spending Dashboard

FDA Details Selective Safety Data Collection in Late-Stage, Premarket and Postapproval Studies In Final Guidance

FDA Off-Label Control Changes Could Be Tested By Pilot Programs; Link “Provisional” Claims To Sentinel Confirmation

Safety Assessment Committees Are “Radical” Feature of FDA’s Revised IND Safety Reporting Procedures

FDA Orphan Drug Designations Reach All-Time High; Resources Needed To Meet Industry Interest In Rare Disease Development

Opioid Abuse: Policy Response Has Implications Beyond Pain

Sentinel’s “IMPACT” Beyond Safety: Anti-Coagulant Study May Tee Up Broader Uses Of FDA Surveillance System For PDUFA VI

Celltrion’s Infliximab Coasts Through “Milestone” Review; Second Biosimilar Precedent For Smooth Panel

CMS Revives, Fortifies State Rebate Negotiating As One of 26 Drug Price Control Proposals In 2017 Budget

FDA’s Budget Moonshot: President Proposes Flat Drug Center Spending, But $75 Million Transfer From NIH

Senate Innovation Bill Starts With Targeted Therapy Provision; Dems Decry Lack Of NIH Funding, But Don’t Attack Pricing

Part B Drug Payment Demo: CMS Will “Test” Alternates To ASP+6%; Building On Lessons Of Sequestration

Celltrion’s Infliximab: FDA Ready to Extrapolate for All Remicade Indications; Agency Answers Challenge of Whether It Can Approve Complex Biosimilars

House Pricing Hearing Displays Patient Assistance In Unfavorable Light; Investigation Enthusiasm From Both Sides

FDA Opioid Action Plan: Bid To Break Califf “Hold” Means More Advisory Committees And A New Look At REMS, PMRs

FDA, CMS Aligned On Biosimilar Tracking; Bipartisan Pressure On CMS To Change Policy – and On FDA To Approve Biosimilars

Cognitive Dysfunction in MDD Is Appropriate Target, Takeda’s Vortioxetine Likely To Get a Labeling Claim