Obesity Drugs and Cardiovascular Outcomes: Will Diabetes Guidelines Be a Good Fit for Weight Loss?

FDA Hearing on OTC Switches: Day Two Focuses on Technology Path to More Switches

FDAAA DTC Guidance: FDA Puts Broad Umbrella Over Which Ads Should Be Pre-Reviewed

FDA OTC Switch Meeting Recap (Day One): FDA’s “New Paradigm” for OTCs Ties New Rules To New Technology

ODAC Supports Accelerated Approval of Talon’s Marqibo; Questions About Proposed Confirmatory Trial Remain

CMS MEDCAC Positive For Anti-VEGF Drugs In DME, With One Blurry Vote On Differences Between Them

Merck/Ariad’s Ridaforolimus: Marginal Benefit Not Sufficient for Maintenance Claim—ODAC

GSK Votrient Sarcoma Use Clears FDA Committee 11-2; “Marginal” Benefit is More Than Enough

Biosimilar User Fee Legislation Sets Reporting Deadline; Possible Augur For First Big Approval Before 2014?

Arthritis Advisory Committee Backgrounder

Marqibo Advisory Committee Redux: Single Arm Study, Low Response Rate May Pose Trouble for Accelerated Approval

Progression-Free Survival in ODAC Spotlight March 20: GSK’s Votrient Label Expansion Likely to Pass Muster, Merck/Ariad Has Tougher Task With Ridaforolimus

PDUFA V: House E&C Discussion Draft Includes Accelerated Approval, Shortages; Supply Chain Content to Come

Drug Review Dossier: CRTX 800

Advisory Committee Backs Lifting Anti-NGF Study Ban, Mitigation Efforts in New Trials

Energy & Commerce User Fee Hearing Highlights Tag-On Priorities; Nothing Too Controversial, But Work Remains

Antibiotic “Special Pop” Proposal Could Be Viable First Step Towards Progressive Approval

House Renews Attention to Prescription Diversion; Legislation May Allow DEA to Enforce Opioid REMS Training

The Regulatory Environment at FDA

Drug Review Dossier: lomitapide

340B Winter Meeting Update: “A New Era of Enforcement and Oversight” Means Improvements For Pharma

E&C User Fee Hearing to Focus on Accelerated Approval, Antibiotic R&D, Pharma Supply Chain

FDA’s Next Biosimilar Public Hearing is May 11: Interchangeability Warm-Up, Round Two

Drug Review Dossier: BG-12

Advisory Committee Tracker: Déjà Vu For New Topics; Key Issue Still What is NOT Going to Panel