Advisory Committee Tracker: New Panels Focus On Old Therapies; August Review Deadlines Include Pfizer Blockbuster

Jetrea for VMA: FDA Advisory Committee Asked to Discuss Breadth of Indication, Need for Additional Safety Studies Pre-Approval

Progression Free Survival Trials Would Be Simplified by Audit Proposal; FDA Oncology Committee Endorses Change

FDA Questions to Ophthalmic Committee on Genentech’s Lucentis DME Indication Focus on Dose: Genentech Urges Lower Dose (0.3 mg Monthly)

Engineering Compliance: GSK Corporate Integrity Agreement Demonstrates Org Chart Approach to Government Control of Research Activities

FDASIA Gives FDA Long To-Do List; Limited Flexibility To Initiate Policy

FDASIA Adds Special Provisions for Rare Disease Applications; Pediatric Voucher Program Worth Watching

Controlled Substances in FDASIA: Hydrocodone Section Shows Continued Pressure On FDA—But Not Mandates For Change

Accelerated Approval Changes in FDASIA: Congress Gives Guidance, But Substance Awaits New Regulation

FDA Recruits Pulmonary/Immunology Specialist from Brand Sector to Head Office of Generic Drugs

FDA GAINs New Authority Over Exclusivity Awards In FDASIA Antibiotic Incentive Provisions

“Breakthrough Therapy” Designation: A New Feature With Uncertain Value

340B Coalition Annual Meeting Update: The Brakes Are On

Extended-Release Long-Acting Opioid REMS Approved; No Substantive Changes

The ABC’s of Special Status: An Alphabetical Listing of Special Designations Available to Drug Sponsors

Advisory Committee Tracker: FDA Adds E&M Dates to Fall Agenda; Will ODAC Be Busy Too?

Drug Shortage Provisions in FDASIA: Manufacturer Obligations Increase; GAO Study Will Set Up Future Provisions

Drug Review Dossier: cysteamine bitartrate

Drug Review Dossier: cobicistat

Drug Review Dossier: bedaquiline

Drug Review Dossier: Elvitegravir

SCOTUS Ruling Shifts Focus to Medicaid On Implementation, Deficit Reduction On Politics For Biopharma

FDA User Fee Bill Passes Senate; FDA’s Quiet Period Ends

The Potential Future of Biopharma Provisions If SCOTUS Strikes Down ACA

The Supreme Court and Biopharma: Preparing for Health Care Reform D-Day