Prevision Policy Clips | Wednesday, August 23, 2017

CDER/Office of Regulatory Affairs Prepare To Meet User Fee Inspection Goals With New “Concept Of Operations”

Commissioner Gottlieb’s FDA Team Takes Shape: Sherman Staying As Principal Deputy Reinforces Sense Of Continuity

FDA Shows Interest in Drug Development for C3G Rare Kidney Disease; Trial Design Issues Highlighted At External PFDD Meeting

Prevision Policy Clips | Tuesday, August 22, 2017

Prevision Policy Clips | Monday, August 21, 2017

DTC Advertising: FDA Signals A Scaled-Back Approach To Risk Information

Prevision Policy Clips | Friday, August 18, 2017

Delay, Delay, Delay: 340B Ceiling Price Final Rule Effective Date Proposed For July 2018; HHS Signals More Pro-Biopharma Rulemaking

Cardiac Rehab Demo Rescinded, Part B Drug Payment Model Still Breathing?

Prevision Policy Clips | Thursday, August 17, 2017

Prevision Policy Clips | Wednesday, August 16, 2017

Opioid Emergency Designation Could Permit Manufacturer Contracts, Stockpiling To Increase Access To Naloxone

Prevision Policy Clips | Tuesday, August 15, 2017

Prevision Policy Clips | Monday, August 14, 2017

Prevision Policy Clips | Friday, August 11, 2017

Prevision Policy Clips | Thursday, August 10, 2017

Zinplava and Stelara Get New Technology Add-On Payments; Blincyto NTAP Expires As Kite Withdraws Request For CAR-T

Prevision Policy Clips | Wednesday, August 9, 2017

Weekly Highlights: July 31-August 4

Pfizer’s Xeljanz Psoriatic Arthritis FDA Approval Likely; AdComm Questions Proposed Claim On Radiographic Progression

Right-To-Try Clears Senate; Modified Bill Assures Drugs Are Under FDA Purview – More Work For FDA, Not More Control

FDARA Clears Senate, With Right-To-Try On Separate Track; “Clean” User Fee Bill Still Adds To FDA To-Do List

Janssen/GSK Plivensia Safety Concerns Outweigh Efficacy: Death Imbalance, Lab Abnormalities Lead to Advisory Committee Rejection

HHS Deputy Team Clears Senate Committee; Preparedness, Opioid Response Are Key Themes – As Is Industry Partnership