SPRINT Act Is Latest Rx Innovation Bill: Alzheimer’s Is Primary Focus, But Model Would Apply to Diabetes, CV Research

FDA/Rx User Fee Renewal Off To Smooth Start: First Hearing Focuses on Ancillary Issues

Drug Review Dossier: Gattex

Advisory Committee Tracker: Forest’s Aclidinium Is Late Addition To February Schedule

Medicaid Rebate Regs Use Broad Definition of Line Extensions

Drug Review Dossier: bosutinib

Drug Shortage Legislation Taking Shape; New House Bill Underscores Focus on Regulation, Not Reimbursement

“Progressive Approval” Dropped From PDUFA Agenda; Accelerated Approval Changes More Realistic for 2012

FDA Advisory Committees 2007-2011: Toughest vs. Easiest

FDA Advisory Committees Voted For Approval Three-Quarters of the Time in 2011; All FDA Decisions Consistent With Panel Votes

Columbia Labs Progesterone Gel Rejected by FDA Advisory Committee; Route for Approval of Unapproved Drugs with Established Uses Is Getting Tougher

Columbia Labs Seeks FDA Committee to Balance Skeptical FDA Staff Review on Progesterone Gel to Prevent Pre-term Deliveries in Women with Short Cervical Length

Pradaxa Bleeding Risk Likely Sentinel Topic; Example of Early Impact of Active Surveillance

Sentinel Update: Statutory Goal Achieved, New Safety Analyses on ARBs, Prasugrel, Gardasil and RotaTeq

Alzheimer’s National Plan Framework Released; FDA/Pharma Not in the Spotlight of First Draft

FDA Sends User Fee Agreements to Congress; Device Proposal Not Ready Yet

Energy & Commerce Announces Upcoming UFA Hearings, On Schedule for Quick Process

CDER’s New Medical Policy Council: Talk Therapy to Forestall Changes to Drug Approval Mandate

Fewer National Coverage Actions Likely in 2012 As Budget Pressures Tighten

Endo Products Caught Up in Novartis Manufacturing Problems

A Big Year for FDA-Biopharma Legislation: New User Fees Should Move Smoothly

Qnexa Returns to FDA: Better Climate for Weight Loss Drug Review, But Better Outcome Unlikely

Advisory Committee Tracker: No News May Be Good News For Apixiban And Vismodegib

Off-Label Information in New Media Age: FDA Ties Safe Harbors to Narrow Answers and One-on-One Contacts

Drug Review Dossier: perampanel