Drug Review Dossier: avanafil

Drug Review Dossier: Relistor for OIC in Non-Cancer Pain

Advisory Committee Tracker: Avastin Month is Here

FDA Advisory Committee Tracker: Schedule Heats Up in June and July; Still Waiting for Potential Dates for Key Applications This Fall

Genentech Hopes Further Avastin Breast Cancer Studies Can Forestall Loss of Indication; FDA’s Drug Center is Adamant That Indication Has To Be Removed

Abbott’s Trilipix: FDA Panel Votes For New Trial, Labeling Changes

Abbott’s Trilipix: FDA Advisory Committee Options Favor Recommendation of Further Study

Generic Drug User Fee Negotiations Appear Behind Schedule

FDA Biosimilars User-Fee Program Would Be Structured Similar to PDUFA “Standard” Reviews

Avastin Hearing Changes Favorable for Genentech, But Still Faces Uphill Battle

Advisory Committee Tracker: New Dates for Endocrine, GI Products Added to Calendar

Lipitor Update: Mylan Case Dismissed As Expected; Next Key Date is June 28

FDA Review Process Changes Included in User Fee Agreement; Fewer Surprises After 2012?

Vertex Telaprevir Records Unanimous Approval Recommendation for Hep C; Protease Inhibitors Will Soon Be Standard of Care, FDA Says – Begins Asking What Will New Sponsors Have to Prove

Generic Lipitor: Ruling in Mylan Case Coming Next Week, Uncertainty Likely to Continue

Merck’s Boceprevir for Hep C (Victrelis): FDA Panel Gives Clear Vote for Approval, Muddled Advice on Labeling for Subpopulations and Postmarket Trials

Vertex’ Telaprevir for Hep C: Approval Recommendation Near Certain But Rash Clearly An FDA Concern

Merck’s Boceprevir for Hep C: Approval Recommendation Not in Doubt; Committee Will Focus on Breadth of Label

Generic Lipitor: Odds Are High For No “True” Generic In 2011

FDA Opioid REMS Released; Final Plan Largely Unchanged From Proposal Discussed Last Summer

LABA Asthma Post-Market Studies: Size of Mandatory Trials Is Breath-Taking; Generic-Discouraging

FDA Opioid REMS Announcement Likely Next Week; Congressional Response Bears Watching

Pharma Provisions in Deficit Reduction Plan: Stronger IPAB, Push for Part D Rebates

FDA Review Times and Industry Fear of Testifying Discussed at Import Safety Hearing

Safety Labeling Changes: FDA Guidance Draws Line Between Mandatory/ ”Voluntary” Based on Who Discovers Signal