Drug Pricing Update: Senate HELP Competition/Price Justification Bill Ready To Move At Year End; Finance Bill Still Waiting In The Wings While HR 3 Heads To Show Vote

Prevision Policy Clips | Bristol/Acceleron Reblozyl Won’t Go To ODAC After All

FDA After Woodcock: OND Reorg Not Prompting Retirements Yet, But The Time Will Come

FDA Earmarked For $2 Billion Boost From Price “Negotiation” Savings In HR 3; Summary Suggests Congressional Priorities For PDUFA VII Process

Correvio Vernakalant For Afib: Sponsor Hoping To Go From Clinical Hold Straight To Approval; FDA Review Suggests Another Rejection Coming

Prevision Policy Clips | House Majority Drug Bill (HR 3) Redistribution Of Drug Expenditure Savings

Choose Your Own Endpoint: FDA Interstitial Cystitis/Bladder Pain Syndrome Guidance Recommends Patients Self-Identify Symptom Endpoints

Prevision Policy Clips | Opioids Return to Advisory Committees

FDA Excipient Review Pilot Could De-Risk Development of Novel Ingredients; Agency Wants Feedback on Idea

Prevision Policy Clips | White House Claims HR 3 Impact On R&D Would Offset Savings

PDUFA VII: What’s On The Table For The Next FDA User Fee Reauthorization?

Antibiotic Labels: Could “Limited Use” Open Up To More Flexible Standards? FDA/IDSA Workshop Highlights Desire For Ways To Communicate Emerging Data

FDA Commissioner Nominee Hahn Clears Committee Hurdle, Looks Headed To Confirmation By Full Senate

Prevision Policy Clips | “Bespoke” Therapies CBER Workshop March 3:

Data Sharing By Drug Sponsors Is Not Generating Flurry Of Negative Lookback Studies; Data Platforms May Not Be Getting Enough Use

Prevision Policy Clips | Surprise ODAC: Four Oncology Products Go To Committee Dec. 17-18

Prevision Policy Clips | Senate Health Committee Moving Forward On Hahn Nomination For FDA

OND Reorg: “Phase III” Delayed To Allow For More Leadership Interviews, FDA Says; Office Directors Confirmed For Most Roles – With One Key Exception

Prevision Policy Clips | OND Reorg: “Phase III” Delayed To January 13

FDA Biosimilar Insulin Guidance: “Switching” Studies Not Required For Interchangeability, Agency Says, If Analytic Data Is “Robust” Enough

Advisory Committee Tracker: Two Big Pharma Cast-Offs Highlight December Agenda – Horizon’s Ophthalmic Teprotumumab And Correvio’s Anti-Arrhythmic Vernakalant

Prevision Policy Clips | FDA Rejects Adamis’ High-Dose Naloxone

Prevision Policy Clips | Certificates of Confidentiality Draft Guidance

Pazdur’s OCE: The Benefits and Risks of Going It Alone At FDA

Prevision Policy Clips | Grassley, Wyden Still Searching For 60 Votes On Drug Pricing Bill