FDA Oxytrol OTC Switch Approval Signals Improving Regulatory Climate for Switch

CMS MEDCAC Invited Presenters Tilt Positive for Lilly’s Alzheimer’s PET Scanning Agent

Ben Venue/Boehringer Ingelheim Generic Injectables Consent Decree: Settling With FDA in a Shortage-Aware Period

FDA Deputy Commissioner for Medical Products and Tobacco Brings Industry Diabetes Experience to New Role

Hydrocodone Combination Products Advisory Committee Preview: No Push to Upschedule

Generic Drug Facility Fee Starts High, Will Get Higher; Overseas Inspection Burden Is Somewhat Lower For FDA

Drug Review Dossier: dolutegravir

FDA “Special Pop” Public Meeting: Opportunity for Sponsors to Build a Case for Broad Pathway, Beyond Antibiotics

J&J’s Canagliflozin: Panel Recommends Approval But 30-Day CV Risk Data Presents A Real Problem For FDA

FDA Abuse-Deterrent Formulation Guidance Stresses “Flexible” and “Adaptive” Approach; Tiered Studies Lead to Tiered Claims

Johnson & Johnson’s Canagliflozin for Type 2 Diabetes: FDA Panel Outcome Resides Squarely On Early CV Risk

Biopharma Policy in 2013: FDA Climate is as Good as it Gets; Debt Debate is Key Obstacle Before ACA Implementation Drives Growth

FDA Advisory Committees Trending More Positive as 2013 Begins; New Review “Program” Will Impact Committee Dynamics

Advisory Committee Tracker: J&J Diabetes Drug First Up in New Year; Depomed/Noven Face Tougher Test on Menopause Drugs

Fiscal Cliff Patch Provides 85 Day Reprieve on Part D Rebates; As “Grand Bargain” Prospects Recede, So Does Rx Risk

FDA Drug Review Dean Temple “Enriches” Drug Development Strategies: Guidance Captures Decades of Wisdom/Experience

A Path to $400 Billion in Health Care Cuts – Without Part D Rebates

FDA Panel Rejects Hemispherx’ Ampligen for Chronic Fatigue: Good Time for New Sponsors To Approach Agency With CFS Candidates

Drug Safety & Risk Management Advisory Committee Backgrounder

Pharmacy Compounding: State Boards Support FDA Position on Regulating “Non-Traditional” Practices; Legislation Likely

FDA Antibiotic Incentives: First Open Meeting on Designating Qualifying Pathogens Features Unified Industry Position

The FDA/CMS Summit for Biopharma Executives 2012: Summary Notes From December 10-11 Conference

Hemispherx Ampligen for Chronic Fatigue: FDA Review Cites Multiple Reasons for Non-Approval

FDA Aims To Standardize Teratogen Advice: Advisory Committee Meeting Focuses on Simplifying REMS

CMS National Coverage Proposal For PET Agents Would Lift Blanket Noncoverage