Paladin On Track For Impavido Leishmaniasis Approval and First Priority Review Voucher For Sale To Another Company

Anti-Infectives Panel Voices Interest In “Tailored-Approach” To Breakpoints But Votes For Simpler Dosing Guidelines

Rx Compounding Bill Awaits Senate Action Post-Shutdown; Colloquy, Not Amendments, Will Be Key To Ease Passage

Hep C Drugs Guidance Update: Major Revisions To Endpoint, Trial Options Underscore Rapidly Moving Science In The Field

ABSSSI Final Guidance: Clinical Response is Decrease in Lesion Size, Reflects Working Group Recommendations

Amarin Vascepa Lipid Claim Needs Outcomes Prior To Approval, FDA Panel Says; Five-Year Delay Likely, New Standard For Class

Anti-Infectives Panel On “Breakpoints” Part Of Larger FDA Approach To Flexible Antibiotic Development

FDA Refuse-to-File Policy Reinforces Principle of PDUFA V: Applications Must Be Complete, Ready-To-Review Upon Filing

ACA Exchange Rollout: Early Launch Resembles Medicare Part D, Mid-November A Key Marker

Amarin Vascepa Review Likely To Follow Accelerated Approval Model: New Lipid Claim Tied To Ongoing Outcomes Study

FDA Manufacturing Enforcement Spans the Globe in First Year After FDASIA; Focus on Indian Injectables

FDA Sets Meta-Analyses Meeting for Nov. 25; PDUFA V Commitment Important for Diabetes Drugs—And Beyond

Antibacterial Unmet Medical Guidance: FDA Webinar Stresses Importance of Preclinical Work and Proof of Unmet Need

FDA Drug Center Stays (Mostly) Open In Shutdown; Pending Applications Still Under Review, But No New NDAs

CMS Retains Clean Final CED Decision On Eli Lilly’s Amyvid For Alzheimer’s, Offers Policy Arguments Relevant To Personalized Medicine

GDUFA FY 2014 Research Priorities Fall Under Quality Umbrella

Compounding/Track-and-Trace Bill Clears House; Senate Likely to Follow Suit But Timing Uncertain

FDA in a Government Shutdown: Still Uncharted Territory for New Drug Reviews

ACA and Pharma: CMS Projects Coverage Provisions To Add Over $13 Bil. Per Year In Drug Spending

Track & Trace Compromise Uses Senate Approach of Unit-Level System in 10 Years; Still Preempts State Laws on Enactment

Rx Compounding Compromise Scales Back Scope Dramatically; Enactment Could Come Quickly

Advisory Committee Tracker: Amarin’s Vascepa and Gilead Hep C Therapy Highlight October Agenda, Assuming No Shutdown

Narcolepsy Patient Meeting: First Rare Disease PDUFA Session Plays to Over-Subscribed Meeting/Webcast

FDA Generics/Quality Leadership Reshuffling Continues; Former OGD Chemistry Head Yu Is New Acting Head of OPS

FDA Oncology Division Responsible For Breast Cancer Therapies Gets A New Director