REMS with ETASU and a Can of Worms: FDA Puts Risk Management Framework for Teratogens to Paper, Feasibility of Targeted Programs for At-Risk Subsets Poses Challenges

Alzheimer’s Drug Policy: Skeptical Take From FDA on Efficacy of Late-Stage Projects; Jan. 30 CMS Meeting Worth Watching

FDA Signals Busy December for Drug Approvals: Full Year Tally for NMEs Could Approach 40

Zogenix Zohydro ER Rejected By FDA Committee: Future of Product (and Class) May Hinge on Tamper-Resistant Formulation

Biosimilars Update: The Health-System Pharmacy Perspective

FDA Has Two “Breakthrough” Designations: Agency Starts To Use New Pathway Quickly

Zogenix Zohydro ER: Single Agent, Single Committee and Single Death Pose Multiple Issues in December 7 Review

Off-Label Ruling Likely to Encourage More REMS From FDA; Sweeping Language Has Broad Implications – But Not Immediately

CBO Endorses Cost-Effectiveness of Drug Therapy in Report; Closing the Donut Hole to Cost Less Under New Scoring Approach

Theravance Appeal Wins Positive FDA Panel Vote on Limited Indication; Broad Nosocomial Pneumonia Use Turned Down

Time for a Plan B in Part D: Rebates and the “Grand Bargain” Deficit Reduction Deal

Advisory Committee Tracker: Zohydro Review Tees Up REMS-Focused December; 2012 NME Total Likely To Beat 2011

CMS Coverage With Evidence Development Guidance Streamlines Criteria for CED; FDA, AHRQ Collaboration Highlighted

Advisory Committee Supports Accelerated Approval Of Janssen’s Bedaquiline for Multi-Drug Resistant Tuberculosis

CMS Proposed National Coverage Decision Topic List Exempts Biopharma; Coverage Policy Threat Now an Opportunity

Theravance Vibativ Label Expansion: FDA Questions to Committee Suggest Limited, No-Other-Alternatives, Use for Nosocomial Pneumonia

Hep C Screening Recommendations Fall Short Of Top Grade, Carry Coverage Implications

FDA's OTC Switch Initiative: Slide Deck Attached

Janssen’s Bedaquiline for TB: Public Health Need Creates Positive Environment for Advisory Committee Review

Essential Health Benefits: No Protected Classes But HHS Bends on One-Drug Standard

FDA Eager For More Master Protocols in Oncology; Approach Offers Cost Savings But Threatens Loss of Sponsor Control

HELP Compounding Hearing: Senate Interested in New Legislation; Discussions in Line With FDA’s Proposal

Accelerated Approval Guidance Likely To Liberalize Use For Targeted Cancer Drugs; FDA Official Supports Incentive For PMCs

Breakthrough Therapy Implementation Update: First Designation Granted, Guidance Likely to Emphasize Manufacturing Issues

E&C Compounding Hearing: Republicans Not Convinced Need for New Authority; FDA’s Interests Align With Proposed Bill