Supply Chain Rules Based on FDASIA Authority: Brand Sector Taking Lead in Proposals for FDA

IDSA VP Joins CDER as Senior Advisor; Emphasizes Antibiotic Priority in Agency, May Diminish “Special Pop” Advocacy

FDA Pediatric Study Plan Guidance Offers Specifics on Timeline of Submissions, Flexibility For 2013 Applications

Lotronex REMS Review: Generic Issues Stay In Background

Lotronex REMS “Update” Supported By FDA Committee; Baby Steps Towards REMS Standardization

CMS Proposes CED for Lilly’s Amyvid; Coverage Available to Enrich Clinical Trials of Alzheimer’s Therapies

Sticky Issue? Lotronex REMS Review Will Focus On Rx Stickers and Alternatives; Generic Barriers Unlikely To Be Discussed

FDA Approvals, Division-by-Division: Oncology Outpaces All Others By Wide Margin In Approvals (and Post-Market Burden)

Lung Cancer Patients Speak Strongly For Risk-Weighted Drug Access: FDA Input Meeting Confirms Primary Focus on Efficacy

Advisory Committee Tracker: First “Program” Application Goes To Committee; Amarin, Salix Face Tough Dates Later This Year

FDA Issues Guidance on Streamlining Trials for Antibacterials for Unmet Need; Potential Model For Special Medical Use?

House Discusses Bills to Modify Part B; Focus On Fixing Physician Payment Cuts, Extend Immunosuppressant Coverage

GSK/Prosena DMD Therapy Gains “Breakthrough” Status; Impact Is Competitive, Not Procedural

Rx Abuse Hearing: CMS Readying Rule To Enroll Part D Providers; Opioid Controls May Be Harbinger for Other Classes

Breakthrough Therapy, Accelerated Approval Guidance: FDA Provides Specifics Without Painting Itself Into Any Corners

CBO Analysis Shows Part D Average Rx Drug Costs Roughly 35% Higher Compared To Rebated Medicaid Costs

GDUFA Regulatory Science Update: FDA Working on Four Areas Beyond Initial List of 13, Requesting Input for FY2014 Priorities

FDA Globalization Rules: Regulatory Process for Virtual Inspections and Good Importer Practices Starts July 12

HIV Cure Research: Further Reflections From June 14 FDA Patient Feedback Meeting

FTC’s Moral Victory On SCOTUS Pay-For-Delay Case May Impact Future Deals, But Also Muddies the Waters

House Compounding Draft Bill Creates State/FDA Notification System; Likely A Non-Starter For FDA, Senate Compromise

DEA Scheduling Delays Get Congressional Attention; Possible Upside for Merck, Eisai

FDA Finalizes Guidance on Codevelopment of Unapproved Drugs; Examples Flesh Out Trial Design, NDA Filing Approaches

FDA HIV Patient Input Meeting Raises Issues Related To Changing HIV Demographics/Comorbidities; Less Guidance on Cure Research Consent Guidance

Prescription Abuse Hearing: Abuse-Deterrent Generics to Be Addressed in Guidance; Hydrocodone Decision Still in Limbo