Sunshine Regs Will Contribute To Repositioning of Pharma Promotion Budgets

Generic Drug User Fee Meeting: FDA Highlights Minimal Cost Impact

FDA On Biosimilars: Either an “A” or “K”—Not Both

FDA Expands Scope of Shortage Reporting Rule; New Definitions Likely to Carry Over to Legislation

Senate HELP Drug Shortage Hearing Focuses on FDA-Based Solutions

Drug Review Dossier: mifepristone for Cushing's

Senate Finance Committee Developing As Favorable Environment For Reimbursement, Other Economic Solutions to Drug Shortages

Affymax’ Peginesatide For Anemia: Narrowed Label, Postmarket Controls Discussion Win Out Over CV Risks

Pfizer’s Axitinib on Track for Second-Line RCC Approval; Model for Non-Breakthroughs in Cancer?

REMS Advisory Committee Discussion Provides View into Future of FDA Post-Market World

Biosimilars User Fee Public Meeting Signals Program Remains On Track

Pfizer’s Axitinib Review: Testing the Climate for Non-Breakthrough Cancer Drugs

Affymax/Takeda’s Peginesatide FDA Panel Preview: It’s All About Safety

Generic Lipitor Approved By FDA: The Dust Settles, But Ranbaxy Doesn’t--Yet

House Republicans Focus on Pricing/Reimbursement Impact on Drug Shortages

Eliquis (Apixaban) Priority Review Reflects FDA Engagement in Third Warfarin Alternative

Advisory Committee Tracker: Fewer Committees in 2011; Fewer Still in 2012?

Generic Lipitor: Playing Out The Scenarios

Drug Review Dossier: apixaban

Drug Review Dossier: Marqibo

Avastin Breast Cancer Indication Withdrawn: Good Outcome for Maintaining Positive Climate at FDA

5-HT4 Agonists for GI Motility Issues: CV Safety Issue Lingers But May Be Subsiding As Approval Hurdle

Q&A: Final MedGuide/REMS Guidance

Salix’ Xifaxan for IBS: FDA Panel Signs Off On New Study, But A Long Way to Go

New Approaches to Cancer Drug Development: Succeed Quickly—Or Else