Salix’ Xifaxan for IBS: FDA Advisory Committee as De Facto Appeal

FDA Appropriations Part of “Mini-Bus”; Conference Report Gives Agency $50M Increase, $234M Below President’s Request

Clinical Trial Infrastructure Repair and Reform Is Getting Sustained Attention

Abbott Trilipix Safety Alert Issued: Mandatory Efficacy Trial May Have Broader Impact

Progressive Approval Legislation Expected Soon; Enactment Unlikely, but Underscores Positive Approval Climate at FDA

FDA “Update” On Makena: Good News For KV, But Still No End to Compounding

Drug Review Dossier: peginesatide

Drug Review Dossier: Axitinib

J&J’s Xarelto Atrial Fib Approval Meets PDUFA Deadline: Labeling Will Pose Issues in Competitive Anti-Coagulant Field

Vytorin Outcomes Claim Clears FDA Committee; Merck May Not Get Broadest Label, But Avoids PR Pitfall

White House Bioeconomy Project: Good Opening for Partnership and Consortia Ideas

ODAC Pediatric Adcomm: FDA’s Pazdur Comments on “Problems” With Accelerated Approval

Vytorin Advisory Committee: Favorable Review and Favorable Panel Suggest Positive Outcome

Advisory Committee Tracker: Important Committees But Few New Products on 2011 Agenda

Affymax/Takeda Follow-On ESA Goes to Oncology Committee in December: Expect Tough Review

Rx User Fees: FDA Stakeholder Meeting Indicates Path to "Clean" Reauthorization

ACO Final Rule Released: Pharma In Good Position

Drug Review Dossier: Aubagio

FDA Proposing Orphan Drug Reg Changes; Clarifications Emphasize Agency’s Push for Internal Improvements Over Legislation

FDA Device Bills Have Provisions With Broader Focus: COI, Mission Statement, and Guidance Schedules

Kohl Bill Goes After Medicare Part B Pricing; Prospects for Action Are Very Slim

FDA REMS Review Dec. 1 Will Focus on Isotretinoin (iPledge)

Rare Disease Update: Describing FDA Past Orphan Flexibility and Other Takeaways

Sentinel Update: Safety Surveillance System Works; Now What?

GAIN Act: Key Antibiotic Incentives Could Be Attractive for PDUFA V Inclusion