Prevision Policy Clips | Drug Pricing Bill Fades As Wyden Walks, Chairman Grassley To Make Last Ditch Effort

FDA Anti-Infective Product Development Guidance For Pediatric Populations Recommends Efficacy Extrapolation Where Appropriate

Advisory Committee Tracker: First “Virtual” Meeting Set For July, With Review Of GSK Myeloma Therapy; NASH Review No Longer Pending After FDA Rejects OCA

Prevision Policy Clips | Gilead Beats ICER Price On Remdesivir: HHS Will Pay $2,300 Per Course Of Treatment

ICER Updates Cost Effectiveness Analysis For Remdesivir To Take Into Account Dexamethasone Trial; Pandemic Assessments May Increase Attention To ICER

Prevision Policy Clips | Senate Appropriations To Hold Operation Warp Speed Hearing July 2

Pandemic Lessons In Continuous Funding: Senate HELP Hearing Features Unity Behind Health Defense Budget, Domestic Manufacturing Investments

FDA Finalizes Community-Acquired Bacterial Pneumonia Guidance; Efficacy Endpoint, Trial Population Updates Among Major Changes

Prevision Policy Clips | HR3 Drug Pricing Provisions Part Of Democratic Election Strategy Bill

COVID-19 Biologics Face Manufacturing Capacity Issues; 60% Of Current Bioreactor Capacity Controlled By Companies With Their Own Biologic Products

Virtual Inspections To Address Pandemic Travel Difficulties May Be Considered By FDA; Video Accompaniment With European Inspectors Is One Option

Prevision Policy Clips | Oncology Center Of Excellence Unveils “Project Patient Voice” With Treatment Symptom Frequency Chart

FDA Amid COVID: Agency Plans To Prioritize Inspections Based On “Expected Health Benefit” – While Still Meeting User Fee Goals; House Hearing Gentle On FDA

FDA May Assess NDA Complexity To Estimate Future User Fee Needs; PDUFA Consultant Suggests Factoring In Post-Market Safety, Guidances

Prevision Policy Clips | FDA Bioavailability/Bioequivalence Sample Compliance Guidance Forwarded To OMB

NCI Seeks To Restart Oncology Trials Engine After Low Accruals During Pandemic; Paying Grantees While Trials Are Stalled Is Spending Down NCI Effort

Prevision Policy Clips | Remdesivir Inhaled Version To Enter Phase I Trials This Week

ODAC Pediatric Committee: Panel Sees Promise In Tessa’s CAR-T, Syndax Therapy For R/R Leukemias; Chair Is Key To Successful Virtual Meeting

Manufacturing Amid COVID-19: FDA Urges Contingency Plans For GMP Compliance In New Guidance

Prevision Policy Clips | ODAC To Review GSK Multiple Myeloma Therapy July 14

ODAC Pediatric Evaluations Go Smoothly In “Virtual” Form; Salarius, Bristol Take Different Approaches To Remote Advisory Committee Talks

Value-Based Pricing In Medicaid: CMS Proposes To Tweak “Best Price” Reporting – Not Create Exemptions

Line-Extension Rebates: CMS Proposes Much Broader Reach For Enhanced Medicaid Rebates On New Formulations

Prevision Policy Clips | Medicaid Rebate Proposal Would Encourage Value-Based Pricing, Dramatically Expand Line-Extension Rebate

“We’re Still Here”: OCE Continues To Move Quickly On Oncology Reviews Amid COVID; First “Virtual” ODAC Coming Soon