FDA Encouraging Companies to Submit Cross-Labeling Applications for Oncology Products: To Reduce Checkpoint Jam And To Help Bring Older Oncology Product Labeling Up To Date

Prevision Policy Clips | Merck “Responsible Pricing” Statement Features 60% Cut To List On Zepatier, Draws Praise From HHS Secretary

FDA To Explore “Temporary, Narrow” Importation To Address Drug Price Spikes Aimed At Off-Patent Price Outliers; Longer Term Implications Could Be Much Broader

FDA Commissioner Office Reorg: Center Directors Will Report Directly To Gottlieb; “Flattened” Structure Intended To Make Future Political Transitions Easier

Prevision Policy Clips | Rebate Reform Rule Coming Soon

FDA Biosimilar Action Plan Does Not Break New Ground: Agency Points To FTC, Medicare Changes As Key; Interchangeability Not Emphasized

First Principles For Real World Evidence: FDA Final Guidance On EHR Use Emphasizes Need To Cite “Data Originator”

Prevision Policy Clips | FDA Finalizes Biosimilar Labeling Guidance As It Prepares For “Action Plan”

FDA Restarts Path Toward NSURE: Draft Guidance Invites Sponsors To Submit Apps, Videos With OTC NDAs

NIH Keeps Close To FDA On Nanoparticle and Prototype-Pathogen Influenza Vaccines; Counting On Familiarity To Shorten Regulatory Reviews

FDA Taking Active Role On Localized Prostate Cancer Trial Design; Floats “Prevent/Delay” Model For Studies In Early-Stage Population

Prevision Policy Clips | Next Step For “Wildcard” Patent Bill Comes In House Mark-Up

Prevision Policy Clips | SIGA Smallpox Drug Awarded First Medical Countermeasure PRV

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