Senate Drug/Device Development Initiative Complements 21st Century Cures, Represents Second Starting Line

Advisory Committee Tracker: Pharmacy Compounding Committee Returns in February; PCSK9 Race Is On

Antibiotics in 21st Century Cures: Limited Population Approval Pathway, Reimbursement Coverage, and “Wildcard Exclusivity”

Rx Exclusivity Incentives Are Core Of 21st Century Cures Draft, And Focus For Critics; Key Issue Is Certainty Versus Patents

Off-Label/Pharmacoeconomic Data Language Still In Flux In 21st Century First Draft; Bill Has Several Important Work-Arounds

DEA Scheduling Reform Remains on House Agenda; Hearing Underscores Support, But No Clear Path To Enactment

“21st Century Cures” Draft Includes “Breakthrough” Approval Pathway: No Negatives For Biopharma, But Long Way To Go

Incentive Proliferation: CNS Advocates Want “GAIN-Plus” For Neurology Drugs; FDA Engages CNS Community

FDA Clarifies cGMP Requirements for Combo Products via New Guidance; “Streamlined” Process Explained and Illustrated

FDA’s Acting Commissioner In Waiting: Duke’s Califf Joins FDA, Brings Strong Relationships With CDER Senior Management

Sen. Warren’s NIH Royalty Bill Shows Risk of 21st Century Cures Process For Biopharma – But Also That Risk Is Very Limited

FDA Pharmacy Compounding Committee Will Review List of Acceptable Bulk Substances In February

Astellas Antifungal Isavuconazole Clears Committee; Another Case Study In Favorable FDA Climate For Infectious Diseases

CMS Advisors To Review Molecular Tests In Oncology; Focus Is On Prognosis, But May Address Palmetto Pilot On Treatment Pathways

State of the Union Includes Increases in R&D Development for “Precision” Medicine, Antibiotic Discovery

Astellas Antifungal Isavuconazole Appears Headed To Smooth Review At FDA Committee; First QIDP Antifungal

Breast Cancer Patient-Focused Meeting Likely To Examine Differences Between Early-Stage and Metastatic Experiences

21st Century Cures: Streamlining Patient Data, sNDAs and FDA Hiring Improvements Among Legislative Recommendations

CMS Transition Should Be Smooth: Slavitt Likely To Serve As Interim Agency Head Through End Of Obama Administration

Drugs and Driving: FDA Draft Guidance Sets Approach To Assess, Study Risk Of Impairment With Psychoactive Drugs

PBM Exclusions in Context: Competitive Impact Important, But Few Brands Are Excluded By Both Express Scripts and CVS

IOM Clinical Trial Data Sharing Recommendations Include Making Study Data Available 30 Days After Product Approval

CDER Office of Pharmaceutical Quality Launches: Important Milestone But Immediate Impact On Manufacturers Is Minimal

Ferring Nocdurna Will Need More Study To Reach US Market; FDA Committee Sides With Agency Objections

Lab-Developed Test Regulation: FDA Workshop Draws Extensive Comment For Changes To Guidance