Prevision Policy Clips | Drug Price Transparency Report Included In Year-End Spending Deal Could Set Up Themes For Next Congress

Lilly Continuing To Produce COVID Antibody Treatments But Looking Ahead To Reassessment In Post-Vaccine Period; mAB Rollout Has Faced Varying Demand

COVID Treatments Seek New Technology Add-On Payments From CMS; Pandemic Could Affect Other Fiscal Year 2022 NTAP Applications as Well

Prevision Policy Clips | Moderna EUA: FDA Calls For Continued Monitoring Of Clinical Trial Investigators

Prevision Policy Clips | PDUFA VII Status Update: Expedited Pathway Evidentiary Standards, Gene Therapy PFDD

Moderna COVID-19 Vaccine EUA Overwhelmingly Clears FDA Advisory Committee; Clinical Trial Unblinding Is Area Of Most Debate

Prevision Policy Clips | FDA Allowing Use Of Extra Doses From Pfizer Vaccine Vials

Nothing Generic About It: Most Unusual Advisory Committee Brings Positive Vote To Expand Heart Failure Indication For Spironolactone

Entresto Gets Cardio-Renal Advisory Committee On Board With Added Heart Failure Claim; FDA’s Stockbridge Leads Discussion On P-Value Flexibility

Prevision Policy Clips | FDA Final Complex Trial Designs Guidance

Smooth Sailing Expected For Moderna: COVID-19 Vaccine Comparable To Pfizer’s; Lower Efficacy In Older Participants May Be One Issue For FDA Committee

Prevision Policy Clips | Moderna Vaccine Second Interim Analysis On Nov. 25 Had Similar Overall Efficacy Against COVID

Opioid REMS Assessment Grinds On: FDA Workshop Participants Agree Imperfect Measure Of CE Impact Is Better Than None At All

No Sponsor? No Problem: Unusual FDA-Initiated Spironolactone HFpEF Review May Help Bolster Novartis’ Case For Entresto Claim

Prevision Policy Clips | CBER Director Marks Says "Pretty Foolhardy" To Conclude One Dose Of Pfizer/BioNTech COVID-19 Vaccine

Novartis Entresto: Benefit-Risk “May Support Approval” For New Heart Failure Claim, FDA Says, But Cardio-Renal Advisory Committee Agreement Wanted

Pfizer COVID-19 Vaccine Gets Strong Endorsement By VRBAC Despite Minor Revolt Over Including 16-17-Year-Olds; Allergic Reactions Headed To Fact Sheet

Prevision Policy Clips | COVID-19 Vaccines: Two Steps Forward, One Step Back

Prevision Policy Clips | Pfizer/BioNTech “Goal” For Full BLA Submission For COVID-19 Vaccine Is 2Q 2021

Biomarin Roctavian Rejection Reflects Different Risk/Benefit Equation In Hemophilia, Not Change In Gene Therapy Standards, CBER’s Marks Says

FDA Provides Mis-Branding Study For Proprietary Name Reviews In Final Guidance; OTC Naming Process Moved Into New Draft Guidance

FDA “Bruised” But Not Broken: Former Commissioners Say “Fundamentals” Remain Solid After Trying Year; Will Biden Team Agree?

Prevision Policy Clips | J&J COVID-19 EUA Will Be Issued In February, After Phase 3 Trial Finishes In January

Pfizer’s COVID Vaccine Has Solid Profile In Subpopulations; Data For Dec. 10 Advisory Committee Shows Broad Consistency In Efficacy And Safety

RT-CMC-R? Industry Wants Real-Time Review Of Manufacturing Submissions For Expedited Products As Part Of PDUFA VII