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"Cures II" Discussion Draft Coming This Summer, But Legislation Delayed Until Next Congress; DeGette/Upton Still Seeking Ideas For Coverage Policy Changes
June 11, 2020
COVID-19 Vaccine Diversity Will Be Key To Combatting Pandemic: “There Will Be More Than One Winner,” Fauci Says
June 10, 2020
Gene Therapy Delays At FDA: Sponsor Meetings May Be Slower, Policy Development Pushed Back Amid COVID – But Enthusiasm Of Regulators Remains High
June 10, 2020
Prevision Policy Clips | Price Controls On COVID-19 Vaccine Would Backfire, NIAID Director Tony Fauci
June 10, 2020
Decentralized Trials Are A Key Theme For FDA As ICH Good Clinical Practice Guideline Revision Gets Under Way
June 9, 2020
Prevision Policy Clips | FDA Allowing Rx Sample Shipment Direct To Patients During COVID-19
June 9, 2020
FDA Will Not Object To Some Device Modifications For At-Home Patient Monitoring And Clinical Decision Support
June 8, 2020
COVID-19 Human Challenge Studies Could Increase Public Trust In Eventual Vaccine; “Warp Speed” Rhetoric May Backfire
June 8, 2020
Prevision Policy Clips | NEHI COVID-19 Immunization Preparedness Plan Calls For Strategy Beyond “Warp Speed”
June 8, 2020
Prevision Policy Clips | CDC Flu Vaccine Contingency Plans To Counter “Difficult Time”
June 5, 2020
Prevision Policy Clips | CDC Director Testifies on COVID Response
June 4, 2020
FDA Trial Conduct Guidance Updated to Include MyStudies App, Additional Information on Remote Endpoints Amid COVID-19
June 4, 2020
FDA “Emergency Use” Process Under Review By GAO As Part Of Broad COVID Response Agenda; Democratic Critics Hit Hydroxychloroquine, Not Remdesivir
June 3, 2020
FDA “Quality Maturity” Ratings Proposal Gains Traction During Senate Finance Hearing; COVID “Spot Shortages” Add To Long-Standing Supply Issues
June 3, 2020
CMMI Oncology Care, BPCI-Advanced Payment Models Will Be Modified Due To COVID-19; No Changes To Part D Models
June 3, 2020
FDA And Congress: Bipartisan Support Tenuous After FDA Leadership Changes, But Senate Committee Steps Carefully Around Hot Topics During Inspection Hearing
June 3, 2020
Prevision Policy Clips | Novartis MS Application Delayed By Three Months; Priority Review Voucher-Supported Supplement
June 3, 2020
Expanded Access During COVID-19: FDA Advises On Ensuring Adequate Risk-Benefit Assessment For Individual Requests
June 3, 2020
Prevision Policy Clips | FDA’s “Warp Speed” Firewall Goes Two Ways: Woodcock On One Side, Hahn And Marks On The Other
June 2, 2020
Routine Immunization Catch Up Efforts May Complicate COVID-19 Response: Big Drop-Off In Measles, Other Childhood Shots After March 13
June 2, 2020
Prevision Policy Clips | FDA Pediatric Oncology Subcommittee Will Review Four Development Plans In Virtual Format June 17-18
June 1, 2020
“Orange Book” Update: FDA Soliciting Comments On Patent Listing Rules, Broader Input On Usefulness of Therapeutic Equivalence Ratings
May 29, 2020
Prevision Policy Clips | “Orange Book” Update: FDA Soliciting Comments On Usefulness Of Therapeutic Equivalence Ratings
May 29, 2020
Prevision Policy Clips | FDA’s Foreign Inspection Program Will Be Focus Of Senate Hearing
May 28, 2020
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
May 27, 2020
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