Generic Drug Sponsors Will Get Status Updates Under New FDA Policy; GDUFA Talks Likely To Include Communication Metrics

Voucher Mania: AbbVie Buys Last Available PRV For $350 Mil.; FDA Adds Diseases Eligible for Tropical PRV

FDA Rare Disease Drug Development Draft Guidance Underscores Role Of Natural History Studies

Purdue Abuse-Deterrent OxyContin: FDA Ties Exclusivity To Label, Not Formulation; Good For Generics But Hurdles Remain

FDA Cautiously Broadening Gold Standard: Describes Changes Underway In Evidence and Analyses at Brookings

Rx Manufacturer Can “Fill In” For Coverage Delays: IG OK’s Program That Provides Free Drug Pending Insurance Approval

Amarin’s Vascepa Win In Court Opens Up Off-Label Promotion But A Major Regulatory Shift May Be Coming

21st Century Cures White Paper

CMS Rejects New Technology Add-On Payment for Astellas Antifungal Cresemba; Grants NTAP for Amgen’s Blincyto

Advisory Committee Tracker: Quiet August But Fall Looks Busy: Repros, Merck and Maybe DMD Sponsors Have Big Days Ahead

21st Century Cures and PDUFA VI: One Bill, Or Two?

FDA Draft “Quality Metrics” Guidance: Agency Asks Whether to Include “Management Engagement” Metrics

Medicare Trustees Report: Part D Spending Poised To Accelerate; IPAB Trigger Could Come In 2017

FDA REMS Meeting Set for October; Focus Is Internal Effort To Minimize Burdens—But Could Tee Up Ideas For PDUFA VI

21st Century Cures To-Do List: FDA Will Have Lots of Deadlines – But Few Regulations To Draft

Vaccine Provisions In Cures Would Change Relationship Of Product Sponsors To CDC; A Rare, Non-Consensus Area of Bill

Biosimilar “Patent Dance” Is Optional, But 6-Month Delay Before Launch is Not, Appeals Court Says In Amgen Vs. Sandoz

Part D And Opioids: House Oversight Hearing Keeps Pressure On CMS To Upgrade Requirements Beyond Pharmacy “Lock-In”

CMS Proposes Antibiotic Stewardship Rules For Nursing Homes; Extends Effort To Cut “Psychotropic” Use To Opioids

340B and Medicare: GAO Report Is Latest Challenge For Purchasers, But Focus On “Incentives” Has Peril For Pharma

340B Reform Bill: Purchasers Respond To House Effort; Time For Manufacturers To Consider What Happens After Legislation?

The Future of the 340B Drug Discount Program: Taking Stock After “Very Challenging” Year For Purchasers

PDUFA VI Stakeholders Ready To Extend, Upgrade Patient-Focused Effort: Clear Consensus Favorite At July 15 Hearing

Cruz’ Take On “Cures”: Tea Party Senator Jumps Into FDA Reform Debate; Sideshow To Main Effort Bears Watching

“Cures” Shifts To Senate After House Vote Caps Remarkable, Bipartisan Process; Final Steps Underscore Perils Ahead