Pfizer’s Chantix: FDA Not Yet On Board With Black Box Change; Broader Trend Of Revisiting Safety Scares

MedPAC Weighs Part D Opioid Use: Lock-Ins Among Proposals, With Eye On Potential To Combat Other Types Of Overuse

FDA Finalizes NCE Five-Year Exclusivity Combo Guidance In Concert With Gilead, Eisai Approvals

The “Real” Start of GDUFA: FDA Works Through Mini-Backlog Prior To Deadline Era; Will Generic Approval Rate Go Up?

FDA 2016-2017 Patient Meetings: FDA Identifies 16 Potential Diseases; Invites Another “Greatest Priority” Debate

DQSA Q&A Guidance Clarifies State Preemption of Tracing Requirements, Licensing Standards

FDA “Critical Path Innovation Meeting” Process Would Build On Duchenne’s Model; Impact Likely To Depend on Funding

FDA Finalizes pCR Breast Cancer Guidance: Perjeta Precedent Cited – Along With Reservations About Neoadjuvant Trials

NIH Report Recommends Research on Chronic Use of Opioids, Multidisciplinary Approach Beyond Pharmacotherapy

Extended-Release Formulations Added To 2015 GDUFA Regulatory Science Priorities

Gilead HCV Oral Fixed Combo To Be Priced Comparably To 12 Weeks of Sovaldi/PEG Interferon/Ribavirin ($95,000)

NIH Report On Long-Term Opioid Use Coming Soon; Workshop Highlights Lack Of Data To Support Chronic Use

Advisory Committee Tracker: Another Clot Drug Heads To Committee; Pfizer Will Fight To Remove Chantix Black Box

IPF Patient Meeting Highlights Severe Unmet Need; Patients Have Difficulty Expressing “Ideal Therapy;” Focus on Oxygen

Rapid Diagnostic Development In Antimicrobials Getting Boost From Drug Sponsors, Progress Appears Slow—NIAID Workshop

BARDA Role in Anti-Infective Development Broadened By Obama Exec Order; Incentive Fund Will Need Legislation

FDA Hemophilia/Inherited Blood Disorders Patient Meeting: Support For Cure Trials; Post-Marketing Surveillance for Safety

Part D Copay Coupons: OIG Underscores Responsibility of the Manufacturer Under Anti-Kickback Law

REMS Standardization Report Sets Table For PDUFA VI Negotiations; FDA Proposes To Study CE Credits As One Project

Generic Sponsor Contact With FDA Is Hot Topic: FDA Hears Sharp Retorts at GDUFA Policy Hearing, Making Changes

Extrapolation of Indications for Biosimilars Appears To Be De Facto FDA Policy, Interchangeability Still "Under Discussion"

Limited Population/Special Medical Use Program For Antibiotics Remains Near-Term Focus Of Legislative Attention For Class

“Wild-Card” Patent Extension Gets Boost In PCAST Antibiotic Report; Opportunity For Economic Incentives In FDA Bill

FDA Panel Rejects Clarus Oral Testosterone; Further Info Needed on Dosing, Food Effect – But Bad Timing Is Main Issue

Antibiotic Incentives Get Full White House Treatment; PCAST Recommendations Will Be Addressed By Feb. 15