Orally Inhaled and Nasal Drug Products: “Light at End of Tunnel” for Alternatives to Clinical Bioequivalence Trials; Pre-ANDA Meetings Will Help

CMS Opioid Response: Part D “Lock-In” Should Begin in 2019; IG Recommends Drug Utilization Reviews For HIV And Antipsychotic Medications Popular With Abusers

Prevision Policy Clips | Pfizer’s Xeljanz sNDA To Gastrointestinal Drugs Advisory Committee March 8

OTC Monograph Reform/User Fee Bill Includes 24-Month Exclusivity Period For New Products; Potential For Less As Bill Advances

Off-Label Formulary Discussion Bill Advances In House; New Version Still Lacks Democratic Support – But Bipartisan Discussion May Continue

Prevision Policy Clips | Off-Label Bill Returns To House E&C

FDA Transparency Initiative Will Release More Clinical Trial Info Upon Approval; Some “Complete Response” Letters May Be Next

FDA/DoD Agreement Grants “Breakthrough” Status For Defense Priorities; CBER Once Again Gets Lead Role In Politically Vital Regulatory Project

Prevision Policy Clips | Enhanced Transparency of Clinical Trial Information Announced by FDA

Prevision Policy Clips | FDA Commissioner Gottlieb to Accompany President Trump to Davos World Economic Forum

Aradigm Effort To Salvage Linhaliq (Ciprofloxacin) With New Endpoint Goes Wrong Way: Earns Committee Rejection For Pending Use

CMS Bundled Payment Model: Part B Drugs Included; Pulmonary/Liver/CV Among Categories Affected

Lipocine’s Oral Testosterone Tlando Rejected By FDA Advisory Committee; Ambulatory Blood Pressure Study Needed Pre-Approval

House 340B Drug Discount Report Calls For Stronger HRSA Oversight And Review Of Hospital Eligibility; Silent On Part B Payment Cut

Prevision Policy Clips | CDER New Drug Report for 2017 Goes Beyond 46 NMEs

Prevision Policy Clips | Bundled Payments for Care Improvement Advanced Model Announced by CMS Innovation Center January 9

Clarus’ Oral Testosterone Jatenzo: CV Risk Leads To Close Panel Vote Against Approval; Restrictive Safe-Use REMS Pushed By Committee, FDA Non-Committal

HHS Nominee Azar Confirmation Expected Soon: Senate Finance Hearing Is Generally Smooth, Sparring Over Rx Pricing

Aradigm Tries To Ride One Study, Two Aligned Endpoints Through FDA Advisory Committee: Second Attempt At An Inhaled Cipro Appears A Longshot

Prevision Policy Clips | Global Blood Therapeutics’ Sickle Cell Treatment Gets FDA Breakthrough Designation

Lipocine’s Tlando Oral Testosterone: FDA Appears Ready To Ask For Another Blood Pressure Monitoring Study Pre-Approval, Will Committee Agree?

Prevision Policy Clips | Lipocine Oral Testosterone Replacement Therapy: FDA Cardiologists Recommend Ambulatory Blood Pressure Monitoring Study

ANDA Metrics Continue On Upswing: FDA Guidances To Sponsors And ANDA “Assessors” Show More Work To Do

Clarus Oral Testosterone Therapy: CV Risk “With Long-Term Use” Is Major FDA Concern; Test Case For Regulatory Flexibility On Safety

Prevision Policy Clips | Clarus Oral Testosterone Replacement Therapy: CV Risk A Concern