FDA Final Orphan Drug Rule Retains Strict “Subset” Approach; Targeting, Toxicity May Define Population; Price May Not

FDA Releases Proposed List of 18 Qualifying Pathogens for Antibiotic Incentives; Inclusion Doesn’t Guarantee Incentive

The Patient Protection and Affordable Care Act Resource Guide

ARB, Anti-Clotting Drug Sponsors Get Good News From Avandia Advisory Committee; Rogue Reviewer Fails To Win Support

Avandia Day Two: “Elephant in the Room” Diabetes Guidance Makes Appearance As FDA Panel Votes To Ease the REMS

FDA Finalizes Injector/Pen Guidance; Increased Emphasis on Human Factor Studies is One Key Change

Avandia Day One: Validation of FDA Approach, Transparency Themes Emerge

FDA Continues to Support Rx Adherence Program; Small Grant Behind Big Theme for Pharma

FDA Updates HIV Guidance Before Patient Meeting: Accelerated Approval Era is Over, But New Rapid Trial Design Proposed

FDA Seeking Comments on Re-Use of NDA Data Submissions: Agency Wades Back into Data Transparency Debate

Avandia Re-Review Will Have Implications for ARB Anti-Hypertensive Class, “Whistleblower” Culture at FDA

Avandia’s RECORD Trial Goes To Panel: Act Four of a Three-Act Play

House Track and Trace Bill Still Moving Fast; Key Hurdle is Compromise With Senate on Preempting California

FDA Rheumatoid Arthritis Guidance Builds On Therapeutic Advances, Has High-Level Attention

Anti-Infective Drug Development Guidances: Next on FDA’s To-Do List Are Uncomplicated Gonorrhea, Diabetic Foot Infections

FDA Lung Cancer Patient Input Meeting: Half-Day Agenda Could Help Open Up QoL Endpoints In Oncology

Advisory Committee Tracker: Quiet Month in June; Moxduo, Sugammadex Face Tough Challenges in July

House Compounding Hearing Reinforces Key Obstacle To Bill: Republican Leadership in No Hurry to Draft Legislation

Part D Hearing Focuses on Lower Prices Vs. Lower Co-pays; Pharma Has New Allies To Support Focus on Access, Adherence

Merck Faces Tough Dose Choices on Suvorexant Following Positive FDA Advisory Committee Review

Lotronex REMS Set For July Committee Review; Another Touchstone in REMS Reconsideration—And Revival of IBS Class

Pharmacy Compounding Bill Moves To Senate Floor, But Avastin Status May Change; House Action Still Uncertain

Track and Trace Bill Moves To Senate Floor, But Folded Into Compounding Bill; Tie Likely to Complicate Passage

FDA REMS Meeting Set For July; Near Term Focus On Nuts & Bolts; Long-Term Implications For Alternative Approval Models

Merck’s Suvorexant Starting Dose Is Unresolved Question for Sleep Agent: FDA Asks Committee If Further Study of Lower Doses is Appropriate