AbbVie/Neurocrine Elagolix for Endometriosis Gets Harsh Treatment From ICER Panel; FDA Extension of Review For Liver Issues Causes ICER Concerns

Drug Shortage Task Force 2.0: FDA Takes Lead – But Reimbursement Policy Is Likely Focus; Time For Essential Drugs List?

GSK Anti-Malarial Tafenoquine Breezes Through Committee; Good News/Bad News For 60 Degrees’ Separate NDA: Approval More Likely, But Priority Review Voucher May Be Gone

Prevision Policy Clips | FDA Forms New Drug Shortage Task Force With CMS, VA

CMS Part B Launch Payment Changes For 2019: Small Payment Cuts; Big Press Release Claims

340B Reform Bills: House Steals Spotlight With Partisan Bills, But Bipartisan Senate Process May Be Only Viable Path For Action In 2018

340B Payment Policy: HHS Not Backing Down On Part B Cuts – But Says “Penny Pricing” Will Be Addressed Soon

Chronic Pain Patients Air Opioid Treatment Access Grievances At FDA PFDD Meeting

Prevision Policy Clips | CMS Proposes Add-On Payment For All New Dialysis Drugs

HHS Deputy O’Brien Sees Transparency Bills As Wasted Effort; Highlights Potential for Administration To Go Beyond Drug Pricing Blueprint

Gene Therapy Efficacy Guidance: Get The Endpoints Right Early, Assume First Study Will Be Pivotal; Accelerated Approval OK in Hemophilia – If Assays Are Right

Gene Therapy Safety: FDA Drops Blanket Request For 15-Year Follow-Up – Though That Will Still Be Expected In Many Cases; “Risk Assessment” Key Step For IND

Prevision Policy Clips | Suite of Six Gene Therapy Guidances Released

Prevision Policy Clips | Tuesday, July 10, 2018

How To Write An Indication: FDA Guidance May Encourage More “Limitations Of Use”; FDA Wants Feedback On Age Range Info

Prevision Policy Clips | House 340B Hearing Has 15 Bills on Tap

Prevision Policy Clips | FDA Draft Guidance On Writing Indications

Prevision Policy Clips | House 340B Oversight Hearing Set For July 11 To Focus On Contract Pharmacy

Advisory Committee Tracker: Anti-Microbials Take Center Stage For The Summer; Four NDAs In July And August

Prevision Policy Clips | ANDA Amendments Final Guidance

FDA Inhaled Antibiotic Workshop Tries To Make Sure Bayer and Aradigm Failures Are Not End Of Topical Bronchiectasis Development

Patient-Reported Outcomes In Single-Arm Cancer Drug Trials Among Challenges Discussed At FDA Workshop; Guidance In The Works

Prevision Policy Clips | Insmed Inhaled Antibiotic Advisory Committee Date Set

“REVAMP”-ed Antibiotic Incentive Bill: “Wildcard” Patent Extensions Would Be Sold With Strings Attached, Including FNIH Royalty

Prevision Policy Clips | PAPHA Antibiotic Amendment Would Give 12-Month Conveyable Exclusivity Award