Prevision Policy Clips | IPI Goes To OMB

Comparative Efficacy And Safety Considerations For Approval Of New Opioids Outlined In FDA Guidance

Prevision Policy Clips | Opioid Comparative Safety/Efficacy Standard To Existing Therapies Suggested In Draft Guidance

Orphan Drug Exclusivity, Generic Labeling Modernization Provisions Are Newbies In Senate HELP Cost Bill; Markup Set For June 26

Insulin Will Be Marker Of Success Of Medicare Part D Rebate Rule; Congress Makes Clear It Will Be Watching For Further Price Decreases

Prevision Policy Clips | Generic 180-Day Exclusivity Decision Status Added To "Orange Book"

PBM/Insurer Mergers Will Facilitate Medical/Pharmacy Benefit Alignment, Economists Tell Senate Hearing; May Increase Pressure On Specialty Drugs

Drug Price Justification Provision Needed In Senate HELP Bill, Democrats Say, But Prospects For FAIR Act Appear Slight; Markup Slated For Next Week

Prevision Policy Clips | NASEM July 24-25 Workshop on NIH Role In Drug Development Is Sponsored By Arnold Foundation

Prevision Policy Clips | DTC Drug Price Disclosure Rule Challenged In Court As First Amendment Violation

Prevision Policy Clips | DEA Places Sage's Zulresso (brexanolone) in Schedule IV

FDA Unlikely to Remove High-Dose Opioids from the Market, May Consider Tougher REMS

Biostatistics Role In OND Overhaul Could Curb “Rogue” Reviewer Problems, Califf Says; Does FDA Have To Worry About Rogue Ex-Commissioner?

HHS IG Review Of Compounding Sources For Hospitals Finds FDA’s Efforts Effective: 89% Use Registered “Outsourcing Facilities”

Prevision Policy Clips | Washington Medicaid Hep C “Subscription” Model Cleared By CMS

Prevision Policy Clips | Alexander-Murray Senate Drug Pricing Bill Has June 18 Hearing Date

Prevision Policy Clips | Final Rule Eliminating Safe Harbors For Drug Rebates In Part D At OMB

Antibiotic Incentives: Last Chance For DISARM Payment Reform? Advocates Urge Immediate Action Before Capital Dries Up

BSUFA Fee Collections “Extremely Volatile” Due To Fewer Applications

Prevision Policy Clips | CDER Director Janet Woodcock Will Testify At June 19 Senate Aging Drug Pricing Hearing

FDA Trial Eligibility Guidance Shows Growing Influence Of Broader Patient-Input Activities On Agency Recommendations In Drug Development

“Bespoke” Therapies: FDA “Rushing” to Develop Policies For N-Of-One Treatments

TB Alliance Pretomanid Clears FDA Committee By Wide Margin – But “No” Votes Merit Attention As FDA Presses Boundaries Of Regulatory Flexibility

Prevision Policy Clips | Generating RWE Through RCTs: FDA/Duke Margolis Workshop July 11-12

FDA NASH With Cirrhosis Guidance: Accelerated Approval Not Recommended