ER/LA Opioid Postmarketing Requirements Public Meeting Scheduled for May; Protocols Due in August

QRx’s Safety Advantage Claim for Moxduo Opiate Combo Is Not A Safe, Well-traveled Route For NDA

“Compassionate Use” Bill Would Allow Sale of Unapproved Drugs to Terminally Ill; FDA Has Faced Similar Pressure Before

Orphan Drug Designations: FDA Seeks Comments on Naming and Limit for Deficiency Letter Responses

“Proven Manager” Burwell Takes Over HHS; Hands On Management for ACA Should Mean Hands Off FDA

Medicare Doc Data Published: Impact On Part B Rx Market May Be To Encourage Lower Cost Therapies, New Payment Models

Obesity Rx Policy Update: Pre-Market Approval Path Working; Post-Market Requirements, Reimbursement Still Uncertain

FDA/DEA Coordination Focus Of House Hearing: Legislative Change Appears To Have Broad Support; Rapid Action Unlikely

Biosimilars Naming Guidance, Potential Administration Hold Up Discussed at House Hearing

Fibromyalgia Sleep and Fatigue Drug Development Issues Interest FDA; Agency Hears Value of Opioids In Chronic Pain

FDA Senate Appropriations Hearing Reflects Attention to Compounding; No Mention of Prescription Abuse

Generic Labeling Rule: FDA Argues For Level Playing Field While Republicans Probe Trial Lawyer Role

FDA Public Meeting on Subgroup Analysis Emphasizes Need for More Over-65 Patients In Trials, Better Labeling Approaches

MannKind Afrezza Clears FDA Panel; Approval Likely – But Labeling “Less Effective” Insulin May Take Time

Durata’s Dalvance Joins Cubist’s Tedizolid In Advisory Committee Celebration For New Skin Infection Options

Cubist’s Sivextro Sails Through Committee, Demonstrates Smoother Path For Anti-Infectives

Advisory Committee Tracker: Moxduo Is Late Addition to April Agenda; Tough Timing For Novel Opioid Formulation

OTC Wise Men Advise FDA To Fix Managerial Problems, Finish Monograph; Don’t Revamp System

House Appropriations Hearing: Interest in Zohydro, Compounding, Generic Labeling, Overseas Inspections

MannKind’s Afrezza: FDA Raises Numerous Concerns But No Smoking Gun; Lung Cancer Signal is One Key Issue

Novartis’ Serelaxin For Acute Heart Failure: No Choice But To Wait For Confirmatory Trial After FDA Panel Rejection

Durata Dalvance Should Have Favorable FDA Advisory Committee on March 31 After Long Start-Stop Development

Cubist Sivextro (Tedizolid) for ABSSSI Headed for Positive Advisory Committee; No Obvious Issues on Efficacy or Safety

OTC Drug Review Overhaul: FDA Listens To Proposals For Short-Cut Fixes for Issues Such as New Formulations

Novartis’ Serelaxin For Acute Heart Failure: First “Breakthrough” To Go To Advisory Committee Faces Steep But Surmountable Challenge