Prevision Policy Clips | CAR-T Safety Label Update: Secondary Malignancy Risk Will Be Added To Black Box For All Agents; Gilead’s Tecartus Stands Out

Prevision Policy Clips | Prolia Gets Boxed Warning for Increased Risk of Severe Hypocalcemia

FDA Revamp Of ORA Will Resolve Inspection Issues More Quickly, Agency Says; Manufacturers Will Need To Learn New Contacts

Prevision Policy Clips | FDA Funded Through March 1 Under Latest Continuing Resolution passed by Congress January 18

Prevision Policy Clips | FDA Commissioner Califf Says Gene-Editing “Biggest New Thing” To “Work Out,” Underscores Agency Officials Are Real-Time “Referees” On AA

Prevision Policy Clips | FDA Updates Shutdown Contingency Plan: 74% Of Staff Would Be Retained

Humira Biosimilar Uptake In Part D Will Be Watched By MedPAC; Benefit Changes In 2025 May Help Drive Adoption, Staff Tells Commission

Prevision Policy Clips | CDER Office Of Compliance FY23 Annual Report

Generic Drug “Reconsideration” Process Updated For GDUFA III; New Guidance Encourages Sponsors To Use Post-CRL Meetings Before Seeking Reconsideration

Prevision Policy Clips | GLP-1 Safety Review: FDA Sees No Evidence Of Causal Link For Suicidality, But “Is Continuing To Look Into This Issue”

Prevision Policy Clips | CTTI/FDA Report Recommends Strategies For Improving Registration And Reporting Of Clinical Trial Summary Results

Prevision Policy Clips | CDER Office Of Regulatory Policy Acting Director Will Be Carol Bennett; Elizabeth Jungman Named Chief Of Staff

Gene Therapy In 2024: FDA’s Marks Wants A “Breakout” Year – Though Ramp Up May Take Longer

CAR-T Safety: CBER’s Marks Calms The Waters After Malignancy Alert, But FDA Likely To Want More Monitoring In Non-Oncology Setting

Prevision Policy Clips | Orphan Drug Label Expansion Analysis

NME Approvals In 2023 Back To Near-Historic Highs, But Some Signs Of COVID Fatigue May Be Showing Up At FDA

FDA Master Protocols Guidance Updates COVID-Focused Advice On Design Considerations; Trial Integrity A Key Concern

Prevision Policy Clips | FDA Commissioner Califf, CBER Director Peter Marks Discuss Vaccine Misinformation

Florida Rx Import Plan Approved By FDA, But Timing And Impact Remain Uncertain; Will First “SIP” Lead To Bigger Gulps?

FDA Advisory Committee Trends 2023: A Tale Two Halves — Fast Start Crashes To Halt; Uncertain Outlook Heading Into 2024

Prevision Policy Clips | Florida Rx Importation Plan Authorized By FDA: Approval Lasts For Two Years

Prevision Policy Clips | FDA’s Casgevy CRISPR Sickle Cell Gene Therapy Approval Included Four Pre-License Inspections

FDA’s Advice For Avoiding Clinical Holds In Gene/Cell Therapy Development: Pay Attention Early To Potency Assurance

Prevision Policy Clips | Geron’s Imetelstat For Myelodysplastic Syndrome To Get ICER Review In July

“Direct-To-Final” Guidances May Increase Under FDA Plan To Enhance Advice Process; Congressionally Mandated Report Notes Increase In Guidance Output Over Past Decade