Avandia Re-Review: A Big Test for FDA Leadership and the Drug Approval Climate

FDA Takes Next Step In Making Complete Response Letters Public; A Positive For Investors But Still A Ways Off

Forest Daxas for COPD: FDA CR Letter Does Not Ask for New Clinical Trials

FDA Drug Marketing Clamp Down: Warning Letters Are Doubling

NicOx Naproxcinod: FDA Advisory Committee Review Hurdles Appear Too High For Positive Outcome

Peripheral and Central Nervous System Advisory Committee: H.P. Acthar Gel for Infantile Spasms Gets Positive Panel Recommendation

Opioid REMS Update: FDA Panel Meeting Pushed Back To Summer, Drug Safety Board Tackles Class-Wide Risk Management Plan

Dendreon’s Provenge Approved By FDA: Pathway for Cancer Vaccines But Not A Major Change In FDA Climate

FDA Advisory Committee Tracker: “Tentative” Dates Could Feature Forest, Orexigen, Arena

King/Acura Acurox Review Documents Posted: Tough Day Ahead, But We Expect Positive Outcome

Oxycontin Post-Marketing Abuse-Resistance Study Will Be Reviewed by FDA Advisory Committee: Implications for King’s Remoxy

Forest Daxas For COPD: Complete Response Letter Looks Almost Certain Due To Lack Of REMS Plan

Daxas For COPD FDA Advisory Committee: Forest Pursues Narrower Indication, But Complicates FDA Advisory Committee Discussion

Orexigen Submits Contrave NDA to FDA; Single Panel for All Three Obesity Drugs Unlikely

Cephalon Jet-Lag Lag: Lessons from Complete Response

Cephalon Oral Fentanyl Product Control Questioned At Congressional Hearing: Relations With FDA Appear Strained

Genzyme: Keys to the Consent Decree Negotiations

Vivus Qnexa Advisory Committee Set: We Remain Cautious on Weight Loss Drugs in 2010

ESAs CMS MEDCAC Meeting: First Half Update

ESAs: CMS MEDCAC Panel Votes In Favor Of Lower Hemoglobin Targets Across Health Measures But Outcome Could Have Been Much Worse For Manufacturers

Pharma/Biotech Health Care Reform Pending: Fees, Donut Hole Close, and 340B

House Sidecar Bill: Another Good Round for Pharma/Biotech

King/Acura Acurox Advisory Committee Scheduled: Unusual Product, Unusual Review but Positive Outcome Likely

Exenatide Weekly: Complete Response Should Allow Second Half Approval

InterMune’s Pirfenidone Clears FDA Committee; Approval Timing Hinges on Post-Marketing Discussion