The User's Guide to PDUFA V (PDF Attached)

GDUFA and BSUFA: Congressional Appropriations Must Kick In For Programs To Start

Novartis Tobi Inhaler Wins Advisory Committee Support; Skeptical FDA Review Still An Issue

Pediatric Provisions in FDASIA Maintain and Add Incentives, But More Requirements and Timelines Too

Split Up HHS? As 2014 Approaches, HHS May Be Too Big To Manage

FDA and AIDS: An Overview -- Slide Presentation

Novartis Tobi Powder Inhaler Faces Skeptical FDA Review At Upcoming Advisory Committee Review

Advisory Committee Tracker: Rare Disease Applications Featured On FDA’s Fall Agenda

Teva’s Neupogen-like Product Approved By FDA Goes Through Full BLA, Not Biosimilar Route

FDA Advisory Committee Votes for Approval of Abbott’s Humira for Ulcerative Colitis

CMS MEDCAC To Reconsider Coverage of Alzheimer’s PET Tracing Agents

AIDS Drug Assistance Programs and Health Care Reform: 2013 Will be a Critical Year

Abbott’s Humira for Ulcerative Colitis: Additional Trials Pre-Approval a Possibility

FDA Publishes Details on Withdrawing Generic Backlog Applications, Two GDUFA Guidance Documents

Get Ready for GDUFA: The New Rules for Generic Drug Reviews

PDUFA V: Holding the Line on Fees

Biosimilars User Fee Act: Up-Front Cost To Sponsors Will Be $200,000 Per IND In FY 2013

FDA Inspection Resources and Authority Enhanced By FDASIA

GW Obesity Outcomes Paper Points To New Ways To Prove Efficacy; Model For Patient-Centered Regulatory Efforts At FDA

Biosimilars Update: Early Analytics the Focus at FDA Pharmaceutical Science Advisory Committee Meeting

Qsymia Certified Pharmacy Network Adds Protections Against Generic Regimens

REMS in FDASIA: Making Modifications Less Burdensome for Sponsors and REMS Less Burdensome for the Delivery System

Senate Hearing On Gray Market Shows Issues Aren’t Black-and-White; Continues Momentum for Track-and-Trace

Advisory Committee Votes In Favor of ThromboGenics’ Jetrea for VMA

Genentech Lucentis Diabetic Macular Edema Use Headed for Approval: Packaging For Doses, Indications May Delay Action