Time To Reconsider Accelerated Approval? OCE’s Pazdur Reflects On Oncology Regulation During – And After – COVID-19

Trial Integrity, Data Interpretability Headline FDA Statistical Considerations Guidance For COVID-Impacted Clinical Trials

FDA Decentralized Trials Guidance: COVID Outbreak Offers Valuable Input But May Delay Timeline; Role For Congress As Well?

Prevision Policy Clips | Statistical Analysis Guidance For Coronavirus-Impacted Trials

FDA Clear Message On First COVID-19 Vaccine Is Necessary To Win Over Public; Surveys Suggest Importance For Agency To Steer Clear From Politics

Prevision Policy Clips | Remdesivir Efficacy May Be Diminished By Hydroxychloroquine, FDA Cautions

CURE ID Database App Expands Into Potential COVID-19 Treatments; Oncology And Rare Diseases Are Next For FDA/NCATS Collaboration

Chloroquine/HCQ Emergency Use Authorization Rescinded By FDA; Political Fallout Will Be Next Step To Watch, But Limited Data Reporting May Be More Substantive Issue

Part D Reform Proposal Formally Sent To Congress By MedPAC, Warns That Revisiting Price Negotiation May Be Next Option

Rx Compassionate Use Criteria Have Been Relaxed By Sponsors During COVID-19: Data Capture Remains Key

Prevision Policy Clips | Lilly Begins Phase 3 Baricitinib Trial For COVID-19

Gene Therapy’s Next Hurdle: Proof Of Commercial Viability; Policy Focus Shifts Squarely To Reimbursement

FDA’s Faster, More Concise Guidance Development Is COVID-19 Silver Lining, CBER’s Marks Says; Biologics Head Also Explains His Move Out Of “Warp Speed”

Prevision Policy Clips | FDA Approves Mylan/Biocon’s “Grandfathered” Insulin Glargine Semglee NDA

Chloroquine Emergency Use Authorization Illustrates Strain On FDA From COVID-19 Workload

Less Talk, More Action? FDA “Right-Sizing” Regulatory Flexibility Must Continue Following Pandemic, Deputy Commissioner Abernethy Says

Prevision Policy Clips | GDUFA III Reauthorization Kick Off Meeting Set For July 21

"Cures II" Discussion Draft Coming This Summer, But Legislation Delayed Until Next Congress; DeGette/Upton Still Seeking Ideas For Coverage Policy Changes

COVID-19 Vaccine Diversity Will Be Key To Combatting Pandemic: “There Will Be More Than One Winner,” Fauci Says

Gene Therapy Delays At FDA: Sponsor Meetings May Be Slower, Policy Development Pushed Back Amid COVID – But Enthusiasm Of Regulators Remains High

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