CMMI Dialysis Demo Discussed Briefly at Senate Hearing; Delay in Launch May Relate to ACO/ESCO Divide

Animal Drug User Fee Bill Clears Senate Committee; No Amendments Added

Animal Drug User Fee Bill Clears Senate Committee; No Amendments Added

GSK/Theravance Breo Committee Review Rescheduled For April 17; Delay Past May Review Deadline Looking Likely

Generic Drugs Office Interim Head Uhl Brings Management, Policy Background

Titan’s Opioid Dependence Implant Probuphine: FDA Focused on Surgical Training and Safety, Dosing, and REMS

Sen. Wyden Rekindles “Reasonable Price” Debate: Pfizer’s Xeljanz is First Target; Focus is Really NIH Funding

Generic Injectables — Slide Presentation

FDA Generic Drug Office Suddenly Rudderless; Geba Departure Means Slower Progress for Generic Issues

FDA to Work with Engelberg on PDUFA V Regulatory Science; PROs, REMS and Risk/Benefit Key Areas

Chronic Fatigue Disease Workshop Will Begin FDA Formal Patient-Input Process from PDUFA V: Meeting on April 25-26

CMS Explicitly Excludes Neurology Uses in Final PET Agent NCD For Oncology Uses

GSK/Theravance Breo Ellipta for COPD: FDA Advisory Committee Postponement Due to Weather, Not Whether NDA is Still on Track

FDA Committee Votes To Withdraw Salmon Calcitonin Nasal Spray For Osteoporosis, but Niche Indication Possible; Oral Calcitonin Must Deliver Fracture Data Pre-Approval

FDA Benefit/Risk Framework To Be Applied to NMEs and New Biologics Starting Next Year

Committee Rejects Noven’s Paroxetine for VMS: Another Drug For Menopause Fails To Clear Efficacy Hurdle

Depomed’s Sefelsa for VMS: Lack of Efficacy Leads to FDA Panel Rejection, Probably the End of the Road

Advisory Committee Tracker: GSK’s Breo for COPD and Titan’s Opioid-Dependance Implant Highlight March Committees

Calcitonin Safety Review: Osteoporosis Claim in Jeopardy; Carcinogenicity Signal Draws Attention to Outdated Efficacy

The Sequester and FDA: Some Negative Impact Likely, but Don’t Believe the Hype

Part D Plans Subject to 85% MLR Threshold: Room for Drug Pricing Flexibility?

Depomed’s Sefelsa for VMS: FDA Says Trials Failed To Show Sustained Efficacy Heading To Advisory Committee

Noven’s Paroxetine for VMS: Approval Rests on Clinical Meaningfulness, Efficacy

FDA Guidance on Companion Diagnostics: Final Guidance Will Have “No Surprises,” Agency Official Says

Animal Drug User Fee Hearing: No Discussion of Compounding, Supply Chain Add-Ons