Generic Drug User Fees: Public Meeting Reveals Few New Details; Final Agreement May Be Released in September

HHS’s Review of Regulations Includes Common Rule, GMPs and Labeling

Adcetris, Zelboraf Clear FDA: Accelerated Approval vs. Accelerated Review in Oncology

Regeneron’s Eylea Faces Three-Month Decision Delay; Still on Track for Approval, Permanent J Code

Generic Drug User Fee Agreement Appears Set; Another Obstacle Removed From PDUFA Reauthorization

FDA Drug Advisory Committees: Post-Marketing Focus Increasing

Biosimilars Update: FDA NEJM Editorial Represents Agency Takeaways from Public Hearing

Pfizer Going OTC With Lipitor? A Steep Regulatory Climb Awaits

FDA Advisory Committees Voting “Yes” Three-Quarters of the Time In 2011

Pfizer Expects Ranbaxy to Launch Generic Lipitor in U.S. after Nov. 30

Prescription Drug User Fee Act Reauthorization Kicks Off With Senate Hearing; Device Issues May Interfere With Rapid Renewal

Advisory Committee Tracker: Panels Added, But What’s Not Going to ODAC May Be Critical

CDER Report Outlines Research Wish List; Closing Gaps Would Lead to Greater Regulatory Clarity

URL Pharma, Avanir Rx Pricing Favorably Treated by Senate Committee Report

Brilinta Approval Highlights Strong FDA Showing in 2011; Expect Slower Second Half

Bristol/AZ Dapagliflozin Rejected by Split FDA Panel; Long-Term Outlook Okay

Drug Review Dossier: Linaclotide

FDA and Biosimilars, Mid-Year Update: Key Themes to Watch

Avastin Takeaways: Prevision Policy Powerpoint Presentation

Bristol/AZ Dapagliflozin: Safety Hurdles Likely to Trip Up Application at Advisory Committee; Long-Term Data May Be Long-Term Answer

Seattle Genetics Adcetris on Track For Accelerated Approval in August: Company Faces Expanded Post-Market Trial Obligations

FDA Restructuring Underscores Key Themes of 2011: Positioning for GOP, Globalization

Seattle Genetics Adcetris: FDA Committee Provides Early Read on Accelerated Approval Confirmatory Trials Post-Avastin

PDUFA Timeline: Accelerated Schedule Puts Pressure on Generic, Biosimilar Fee Talks

The Avastin Decision: House Panel Applies Gentle Pressure to Preserve Access