CDER Officials Commit To Maximum Flexibility On COVID-Related Study Issues, But Acknowledge “We Can’t Perform Magic”

Prevision Policy Clips | What Happens To The ACA Now? Biosimilar Pathway, Rx Rebates/Fees

Biogen’s Aducanumab For Alzheimer’s: Committee Stop Looks Like A Formality As Collaborative FDA Is Ready To Approve For “Enormous” Unmet Need

ICER Prepares For Hemophilia Gene Therapy: Hemlibra Will Be A Tough Act To Follow

Prevision Policy Clips | HR3 Likely A Goner, Compromise Drug Pricing Bill Could Gain Momentum

Office Of New Drugs Reorg Seen As Success By FDA, But Staffing Constraints, COVID-Related Virtual Training, Complicates The “New Normal”

PDUFA VII Themes Emerge: Complexity Of Products, Trial Designs, And IT Will Be Key Focus For Discussions; Six Working Groups Conducting Negotiations

Hydexor REMS Not Enough To Allay FDA Panel Concerns, But Still Enough To Work With If FDA Wants To Approve—But Why Would They?

Prevision Policy Clips | FDA Transparency During COVID Is Commendable Despite External Political Pressure, Former FDA Deputy Josh Sharfstein

FDA Integrated Review Document: Goal Is To “Elevate” Disagreements, Not “Minimize” Them; Stakeholder Feedback Stresses Desire For More Info On Failed Trials, Pre-NDA Advice

Prevision Policy Clips | CDC “Jurisdictional Readiness Date” For COVID Vaccines Is Nov. 15

FDA Reconsidering Accelerated Approval: Late Confirmatory Trials Continue To Vex Agency; Makena Demonstrates Absence Of Regulatory Teeth

Prevision Policy Clips | Medicare Part D Plans Excluded From Pricing Transparency Rule

Fourth Time’s A Charm? Hydexor Could Get FDA Panel Positive Recommendation With Narrowed Indication, REMS Plan

Gene Therapies At FDA: Duration Of Effect A Concern, Pre-Approval Inspections Will Evolve, OTAT Director Bryan Says

Advisory Committee Tracker: Aducanumab At Last, But Alzheimer’s Review May Be Upstaged By COVID Vaccine; “Back From Failure” Theme Continues With CHF Reviews

Prevision Policy Clips | COVID-19 Vaccine Coverage Rule From CMS Assures No Cost To Patients

CBER-Specific Discussions For PDUFA VII Include Leveraging “Sponsor-Specific Prior Knowledge” On Gene Therapies, Funding For RMAT Program

HR 3 And The Election: Drug Price Control Prospects Under Different Scenarios

Prevision Policy Clips | Pfizer/Lilly Tanezumab Needs AdComm After All; Review Will Extend Into 2021

Prevision Policy Clips | Gene Therapy Duration Of Effect An FDA Concern, CBER's Wilson Bryan Says

COVID-19 Vaccine Sponsors Will Need To Continue Clinical Trial Blinding Following EUA, FDA Says; Likely Key Topic For Upcoming Panel Reviews

COVID Vaccines Will Have Efficacy Data Challenges Following Release: Durability, Severe Disease Studies First; More Comparative Studies Likely

Prevision Policy Clips | Would FDA Be Affected By Schedule F? Trump Executive Order

FDA Vaccines Advisory Committee Primed For COVID Emergency Use Applications: Members Reassured Of “Relatively High Standard” Prior To Candidate Reviews