FDA-Sponsor Enhanced Communication Program: Facilitators, Not Deciders

Compounding Hearings: Expect Tough Tone For FDA; “Do Not Compound” List Highlights Innovator-Friendly Provisions in Bill

Merck “Oxytrol for Women” Gets Split Vote (5-6) From FDA Advisory Committee: Agency Seems Favorably Inclined To Switch Application, OTC Product Still Has Chance of Approval

Novo Nordisk’s Degludec: Panel Recommends Approval With Outcomes Trial, But Is It Enough For FDA?

Merck/Watson “Oxytrol for Women” OTC Switch: FDA Review Is Neutral to Positive But Committee Composition Raises Issues for Sponsors

FDA Committee Unanimously Recommends Novartis’ Signifor for Cushing’s Disease; Approval Likely in Near-Term

The Elections and Biopharma: Status Quo Generally a Good Outcome

Novo’s Insulin Degludec: FDA Review Likely to Lead to Committee Rejection

Novartis Signifor: FDA Committee Asked to Weigh Risk/Benefit Ratio Given Hyperglycemia Adverse Event

Pradaxa Safety Review Shows How Fast Mini-Sentinel Can Elaborate on (and Correct) First AERS Reports

Compounding Crisis Brings Push For New Legislative Authority for FDA: Odds Low, But Not Zero

FDA Patient Input Initiative Will Need Formal Process and Bedside Manner

How FDA Picked the First-Cut List of 39 Diseases for Patient Input

IPAB Stuck In Neutral: No Appetite to Move Forward But Who Could Serve If Board Advances?

Advisory Committee Tracker: FDA Shuffles Fall Line-Up; Novo’s Insulin Degludec Highlights November Agenda

Patient Perspectives Will Help FDA With Post-market Safety Issues As Well As Drug Development Pathway

Hydrocodone Combination Products Advisory Committee Preview: No Push to Upschedule

Novo Insulin Degludec Review Will Focus on CV Risk Versus Hypoglycemia Benefit, FDA Discloses

House Energy & Commerce Hearing On Meningitis Outbreak Expected Post-Election

GDUFA Application Fees Public: Backlog Fee Lower Than Projected, Reflecting ANDA “Rush” in September

Mini-Sentinel Moves to Next Level: Protocol-Based Assessment of a Large Multi-Product Category – ACEs/ARBs/Tekturna and Angioedema

Genzyme/Isis Mipomersen Clears Advisory Committee; Support Less Enthusiastic Than For Aegerion’s Lomitapide

Aegerion’s Lomitapide: Use Restrictions To Narrow Population Secure Positive FDA Committee Vote

FDA Committee Supports Approval of NPS’ Gattex; Additional Work Needed on Postmarket Registry

Genzyme/Isis Mipomersen Review Parallels Aegerion’s Lomitapide: “Yes” Votes Likely in Both Cases