Aegerion’s Lomitapide: Staying On-Label Is Key To Get Through FDA Advisory Committee

NPS’ Gattex for Short Bowel Syndrome: Advisory Committee Focus Likely on Post-Market Controls, Not Approvability

Medicare Coverage with Evidence Development Guidance, NCD Topics List Coming Soon

Making Cancer Care Affordable: Rx Prices Are Secondary Focus, But Bundling Is Prominent During IoM Discussion

FDA Next Step in Rx-to-OTC Switch Initiative Will Be Workshops With Brookings

Novartis Tekturna Angioedema Data From Mini-Sentinel FDA Surveillance System To Be Highlighted in Two Weeks

Thoughts on TransCelerate: R&D Leadership Provides Unique Consortia Focus

Advisory Committee Tracker: Celgene Gets Committee Date for Pomalidamide; Infectious Diseases Dominate Fall Calendar

President’s Council Report on Drug Development Underscores Favorable FDA Climate; Emphasizes Existing Tools

FDA Launches Antibiotic Task Force to Implement GAIN Act

FDA Patient Input Process: Agency Will Start With Open Meetings on a Dozen Diseases over Next Three Years

“Track-and-Trace” Prospects Dimming Fast, Despite Ongoing Talks on Capitol Hill

Rx User Fees Should Start Smoothly After GDUFA “Fix,” But Sequestration Looms

Generic Drug User Fees Update: Implementation Moving Forward Despite Uncertainty

Pandemic and Hazards Preparedness Bill: Still a Slim Chance in 112th Congress

GAIN Act Exclusivity Designation Highlights Next-In-Line Antibiotics Developers

First FDA “Breakthrough” Designation Could Come by Mid-November

Sunburn in 2013? Lack of Sunshine Regs Makes Compliance a Guessing Game

FDA Budget Would Be Hit With $318 Mil. Reduction Under Sequestration, User Fees Not Exempt

West-Ward Clears First Step to Approved Status for Injectable Phenylephrine

Ariad Ponatinib May Be Candidate For Rapid FDA Approval

Cornerstone’s Lixivaptan: “Modest” Efficacy Not Enough For FDA Panel: Both Indications Rejected

Pediatric Advisory Committee Reviews Labeling for Cadence's Ofirmev to Minimize Confusion/Overdose in Children

West-Ward Injectable Phenylephrine Should Clear Committee But Faces Uphill Fight For Broad Indication

Cornerstone’s Lixivaptan Advisory Committee Preview: Dual Indications Sought, Only One Has A Chance