CMS Exchange Final Rule Includes Rx Drug Exceptions Process for “Exigent” Circumstances

House “21st Century Cures” Project: Taking Patient-Focused Drug Development to the Next Level

FDA/IOM Risk-Benefit “Uncertainty” Workshop: Better Communications Still Means Better Label

Senate Caucus on Narcotics Control: New Addiction Treatments, Mandatory Monitoring Program Usage, Prescriber Ed Discussed

PAH Patient Meeting: Shortness of Breath Worst Symptom; FDA Sensitive to Cumbersome Treatments

Zohydro Makes A Cameo At Senate Finance Committee HHS Confirmation Hearing

FDA Issues New Biosimilar Guidance on PK/PD: No Surprises; Fleshes Out Case-By-Case, Step-Wise Development Path

Track and Trace: Industry Wants Interoperable Standards Guidance to Come Before November, Allow Flexibility

FDA Drug Quality Initiatives: EU Collaboration Adds Staff, While Drug Center’s OPQ Launch Still Pending

HHS CEO: Regulatory Predictability, IPAB Repeal Discussed During Smooth Confirmation Hearing For Burwell

“21st Century Cures”: Initial Themes Include Building On “Breakthrough,” Clinical Trial Reform; CMS Perspective Lacking

House “21st Century Cures” Process Kicks Off: NIH Funding Gets Top Billing, But Key Message Is Bipartisan Idea Collection

ASCO Proposes Payment Reforms Structured Around Code Consolidation, But No Specifics on ASP+6%

Merck Singulair Allergy Derailed; Two 11-4 Votes Against OTC Application Leave Little Chance To Sustain Prominent Brand

Inborn Errors of Metabolism Patient Meeting To Focus on Neurological Manifestations, Consent Issues for Children

OIG Recommends Enhanced CMS Tracking Of Claims, Payments For Compounded Drugs In Part B: CMS Tepid In Response

The “3Ds” Make Their Debut: Energy & Commerce Effort Has Grand Plans But Hard To Ignore PDUFA VI

Senate DEA Oversight Hearing: Another Chance To Debate Zohydro; No Mention of Rx Scheduling Delays

Merck’s Singulair Allergy OTC Switch Faces FDA Concerns Over Off-Label Asthma Use, Weak Efficacy; Committee Review May 2

Advisory Committee Tracker: FDA Will Take First PARP Inhibitor To Oncology Panel In June; Chantix Safety Review Set For Fall

Solving Rx Abuse Without FDA? House Hearing Suggests Using Anti-Addiction Medication More, Opioids Less

“Expedited” Device/Diagnostics Guidance Uses “Breakthrough Therapy” All-Hands-On-Deck Approach

QRx/Actavis’ Moxduo Morphine/Oxycodone Combo Rejected By Advisory Committee; Path Forward Unlikely

Orphan Drugs And Biosimilars: MAb Guidance Makes Clear Orphan “Sameness” Standard Is Separate From Biosimilarity

Pharma Fee Gets OIG Attention: Over $8 Billion Collected to Date With Only Minor Bumps Along The Way