Antibiotic Incentives: Last Chance For DISARM Payment Reform? Advocates Urge Immediate Action Before Capital Dries Up

BSUFA Fee Collections “Extremely Volatile” Due To Fewer Applications

Prevision Policy Clips | CDER Director Janet Woodcock Will Testify At June 19 Senate Aging Drug Pricing Hearing

FDA Trial Eligibility Guidance Shows Growing Influence Of Broader Patient-Input Activities On Agency Recommendations In Drug Development

“Bespoke” Therapies: FDA “Rushing” to Develop Policies For N-Of-One Treatments

TB Alliance Pretomanid Clears FDA Committee By Wide Margin – But “No” Votes Merit Attention As FDA Presses Boundaries Of Regulatory Flexibility

Prevision Policy Clips | Generating RWE Through RCTs: FDA/Duke Margolis Workshop July 11-12

FDA NASH With Cirrhosis Guidance: Accelerated Approval Not Recommended

Prevision Policy Clips | NASH Drug Development Guidance

Prevision Policy Clips | OND Re-Org “Might” Be Final This Year, CDER Director Janet Woodcock Tells BIO

Save The Date: Biopharma Congress V On October 7: Confirmed Speakers Included Grogan, Gottlieb, O'Brien

TB Alliance Pretomanid Likely Headed To Approval: Non-Traditional Sponsor, Unusual Clinical Program – All In A Day’s Work For FDA

Prevision Policy Clips | FDA Chief-of-Staff Will Be Lenihan Folllowing Departure Of Lauren Silvis

Advisory Committee Tracker: New Cholesterol Therapies May Skip Advisory Committee Stop; Esperion Is Off The Hook Already – Will Amarin Also Get A Pass?

Prevision Policy Clips | FDA Formally Launches “Project Facilitate”

Providers Ask FDA to Modify Rules for Compounding for Office Stock; Eye Infections Demand Quick Treatment – But Small Batches are Unattractive to 503B Outsourcing Facilities

Prevision Policy Clips | CDER Deputy Throckmorton Is Drug Center Rep On CBD Team

FDA Unit-Of-Use Mandate For Opioids Would Require Three Package Sizes, But No Explicit Dosing Recommendations

Prevision Policy Clips | FDA Proposal To Mandate Unit-of-Use Packs for IR Opioids

ICER Review Of Novartis MS Drug Siponimod Focuses On Coverage Impact Of “Surprise” FDA Statement

Prevision Policy Clips | FDA Cancels Aug. 8 Adenoviral Infection Drug Development Workshop

ICER Reviews Janssen’s Esketamine for TRD: Restricted Distribution May Require Less Utilization Management By Payers, But Access for Patients Remains a Concern

Prevision Policy Clips | Novartis Launches New Era For Curative Gene Therapy With New Price Milestone

First Amendment Challenge To Trump DTC Price Disclosure Rule Under Debate: First Response Is “Comply With Context”

Prevision Policy Clips | Friday, May 24, 2019