FDA and Patient Input: ALS “Considerations” Meeting Is Next Learning Step for Agency

LPAD “Special Population” Pathway for Anti-Infectives: Pew Meeting Debates Trade-Offs; Issue Has Relevance Beyond Antibiotics

Second-Line Status For Biologics in RA Among Few Rx Items on “Choosing Wisely” Lists; Procedures, Testing Dominate “Don’ts”

EHB Final Rule: Use of Benchmark Plans to Set Minimum Number of Drugs Covered Becomes Two-Year Transition Policy

The 113Th Healthcare Congress: Full Committee Leaders Relatively Unchanged, Moves at Subcommittee Level

Part D Rebates Overhang or Hangover?

AIDS Drug Assistance Program 5% Cut Featured on HHS Sequester Pain List

HHS OIG Study On REMS: FDA Likely To Increase Monitoring Of Assessments

IOM National Cancer Clinical Trials System Meeting: Takeaways from FDA Oncology Director Richard Pazdur

Third CDER Deputy Elevates Orphan Drug Emphasis into Top Management at FDA Drug Center

CMS Sunshine Rule: Patient and Nurse Practitioner Materials Protected from Disclosure; CME Distinctions Added

FDA Proposed Early-Stage Alzheimer’s Drug Guidance: Agency Adopts Optimistic Tone But Few Specific Trial Criteria

Dialysis Comprehensive Care Demo Will Test ACO-Like Model in up to 20,000 Patients; Experiment Could Provide Blueprint For Other Diseases, Like Cancer

Advisory Committee Tracker: Quiet Month For Panels, But Key Events Include ALS, Opioid Hearings, First “Late-Cycle” Meeting

“Special Pop” Public Hearing: Potential Beyond Antibiotics, But Plenty of Issues to Work Out

Sentinel Grows Up: Next Steps Include Making Surveillance More “Active”—and Finding Sustainable Funding Model

FDA Proposes Voluntary Approach to Update Labeling for Generics, Older Brands; Contractor May Do Revisions

Pradaxa, Prevnar, IVIG and LABAs in Sentinel Safety Spotlight

Eli Lilly’s Amyvid for Alzheimer’s: MEDCAC Panel Votes Down PET Agent, Local Carrier Discretion The Most Likely Course for CMS

Pharmaxis Bronchitol For CF: New Study Needed For Approval in US After Committee Rejects Application

Boehringer Ingelheim’s Striverdi (Olodaterol) COPD Inhaler Wins Solid FDA Advisory Committee Endorsement; Exercise Tolerance Claim in Limbo

The 340B “Cliff”: Discount Program “Under Stress” as Political Patrons Change, Audits Begin; Major Reforms Unlikely This Year

FDA Advisory Committee Votes to Restrict Hydrocodone-Containing Products; FDA Likely to Follow Suit

Pharmaxis Bronchitol For CF: Statistical Issues Cloud Efficacy; FDA Skeptical of Pediatric Use

Boehringer Ingelheim’s Striverdi (olodaterol) Review by FDA Advisory Committee Likely to Focus More on New COPD Claims (Exercise Improvement) Than Approvability