Endo Next Version Opana ER Avoids Challenging, Full-Agenda FDA Advisory Committee on Dec. 2

FDA and Biosimilars: Key Takeaways and Themes from the Two-Day Meeting

FDA Biosimilars Public Meeting: Positioning For 2011-2012

Advisory Committee Tracker: Oncologics Added to December Calendar

Opioid “Abuse Deterrence” Claim Faces Tough Regulatory Hurdle; Narrower Claims Urged –“Injection-Resistant,” “Snorting-Resistant”

Drug Review Dossier: pixantrone

Drug Review Dossier: linaclotide for IBS-C and CC

Bydureon Complete Response Letter Puts FDA Decision in 2H 2012; Regulatory Options to Bring Swifter Action Limited and Unlikely

Opioid Entry Barriers: FDA Discusses Post-Marketing Requirements

Drug Review Dossier: Kalydeco

Medicare Implications: FDA Advisory Committee Votes Not To Restrict ESA Use in Dialysis, Leaves Pre-Dialysis Limits Up To FDA

FDA and ESAs – Midday Update

PDUFA V Negotiations Underscore Reality of Longer FDA Review Times for New Drugs

Amgen’s Aranesp: FDA Briefing Documents Increase Uncertainty Going into Advisory Committee

Pfizer Has Relevant Experience, Resources to Advance Remoxy, Crack Open Purdue Frederick’s OxyContin Franchise

Vivitrol Opioid-Dependence Approval Starts Big Month for Alkermes; Bydureon Up Next on October 22

FDA Goes Against Its Advisory Committees a Quarter of the Time

Abbott Agrees To Withdraw Meridia: A Slight Positive for Other Weight Loss Drugs

FDA Commissioner Margaret Hamburg at National Press Club: FOBs and More

Biosimilars Kick-Off Meeting Officially Set For Nov. 2-3; Final Notice Punches Up “Safety First” Theme

Advisory Committee Tracker: Benlysta Headlines Remaining 2010 Committee Schedule

Drug Review Dossier: carlfizomib

Gilenya Approval; Avandia Restrictions: Two Different Views of Pro-Approval Climate at FDA

FDA To Restrict Avandia Use: Okay For GSK, Good For Biopharma

Generic Drug User Fees Primer: Inspection Resources Top FDA's Wish List; Sponsors Want To Cut Backlog