Prevision Policy Clips | Price Controls On COVID-19 Vaccine Would Backfire, NIAID Director Tony Fauci

Decentralized Trials Are A Key Theme For FDA As ICH Good Clinical Practice Guideline Revision Gets Under Way

Prevision Policy Clips | FDA Allowing Rx Sample Shipment Direct To Patients During COVID-19

FDA Will Not Object To Some Device Modifications For At-Home Patient Monitoring And Clinical Decision Support

COVID-19 Human Challenge Studies Could Increase Public Trust In Eventual Vaccine; “Warp Speed” Rhetoric May Backfire

Prevision Policy Clips | NEHI COVID-19 Immunization Preparedness Plan Calls For Strategy Beyond “Warp Speed”

Prevision Policy Clips | CDC Flu Vaccine Contingency Plans To Counter “Difficult Time”

Prevision Policy Clips | CDC Director Testifies on COVID Response

FDA Trial Conduct Guidance Updated to Include MyStudies App, Additional Information on Remote Endpoints Amid COVID-19

FDA “Emergency Use” Process Under Review By GAO As Part Of Broad COVID Response Agenda; Democratic Critics Hit Hydroxychloroquine, Not Remdesivir

FDA “Quality Maturity” Ratings Proposal Gains Traction During Senate Finance Hearing; COVID “Spot Shortages” Add To Long-Standing Supply Issues

CMMI Oncology Care, BPCI-Advanced Payment Models Will Be Modified Due To COVID-19; No Changes To Part D Models

FDA And Congress: Bipartisan Support Tenuous After FDA Leadership Changes, But Senate Committee Steps Carefully Around Hot Topics During Inspection Hearing

Prevision Policy Clips | Novartis MS Application Delayed By Three Months; Priority Review Voucher-Supported Supplement

Expanded Access During COVID-19: FDA Advises On Ensuring Adequate Risk-Benefit Assessment For Individual Requests

Prevision Policy Clips | FDA’s “Warp Speed” Firewall Goes Two Ways: Woodcock On One Side, Hahn And Marks On The Other

Routine Immunization Catch Up Efforts May Complicate COVID-19 Response: Big Drop-Off In Measles, Other Childhood Shots After March 13

Prevision Policy Clips | FDA Pediatric Oncology Subcommittee Will Review Four Development Plans In Virtual Format June 17-18

“Orange Book” Update: FDA Soliciting Comments On Patent Listing Rules, Broader Input On Usefulness of Therapeutic Equivalence Ratings

Prevision Policy Clips | “Orange Book” Update: FDA Soliciting Comments On Usefulness Of Therapeutic Equivalence Ratings

Prevision Policy Clips | FDA’s Foreign Inspection Program Will Be Focus Of Senate Hearing

Missed User Fee Deadlines: FDA Steps Up Contingency Planning With Q&A Guidance; NDA/BLA Applicants Will Be Notified Of Delays, Generic Applicants Will Need To Ask

Advisory Committee Tracker: Empty Calendar As FDA Delays Intercept NASH Review; “Virtual” Meetings Are Still Expected This Summer

Prevision Policy Clips | Missed User Fee Deadlines: FDA Promises To Alert Sponsors Of Delays In Application Reviews Amid COVID

House Energy & Commerce Leadership Demands Warp Speed Response From Trump On How “Operation Warp Speed” Layers Onto Existing Programs