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MIE Time? FDA Urging Participation in Generic Drugs Model-Integrated Evidence Meeting Pilot; Says Modeling Will Be “Essential” For Future Of Generic Development
January 23, 2024
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
January 23, 2024
Prevision Policy Clips | Prolia Gets Boxed Warning for Increased Risk of Severe Hypocalcemia
January 22, 2024
FDA Revamp Of ORA Will Resolve Inspection Issues More Quickly, Agency Says; Manufacturers Will Need To Learn New Contacts
January 19, 2024
Prevision Policy Clips | FDA Funded Through March 1 Under Latest Continuing Resolution passed by Congress January 18
January 19, 2024
Prevision Policy Clips | FDA Commissioner Califf Says Gene-Editing “Biggest New Thing” To “Work Out,” Underscores Agency Officials Are Real-Time “Referees” On AA
January 18, 2024
Prevision Policy Clips | FDA Updates Shutdown Contingency Plan: 74% Of Staff Would Be Retained
January 17, 2024
Humira Biosimilar Uptake In Part D Will Be Watched By MedPAC; Benefit Changes In 2025 May Help Drive Adoption, Staff Tells Commission
January 16, 2024
Prevision Policy Clips | CDER Office Of Compliance FY23 Annual Report
January 16, 2024
Generic Drug “Reconsideration” Process Updated For GDUFA III; New Guidance Encourages Sponsors To Use Post-CRL Meetings Before Seeking Reconsideration
January 12, 2024
Prevision Policy Clips | GLP-1 Safety Review: FDA Sees No Evidence Of Causal Link For Suicidality, But “Is Continuing To Look Into This Issue”
January 12, 2024
Prevision Policy Clips | CTTI/FDA Report Recommends Strategies For Improving Registration And Reporting Of Clinical Trial Summary Results
January 11, 2024
Prevision Policy Clips | CDER Office Of Regulatory Policy Acting Director Will Be Carol Bennett; Elizabeth Jungman Named Chief Of Staff
January 10, 2024
Gene Therapy In 2024: FDA’s Marks Wants A “Breakout” Year – Though Ramp Up May Take Longer
January 9, 2024
CAR-T Safety: CBER’s Marks Calms The Waters After Malignancy Alert, But FDA Likely To Want More Monitoring In Non-Oncology Setting
January 9, 2024
Prevision Policy Clips | Orphan Drug Label Expansion Analysis
January 9, 2024
NME Approvals In 2023 Back To Near-Historic Highs, But Some Signs Of COVID Fatigue May Be Showing Up At FDA
January 8, 2024
FDA Master Protocols Guidance Updates COVID-Focused Advice On Design Considerations; Trial Integrity A Key Concern
January 8, 2024
Prevision Policy Clips | FDA Commissioner Califf, CBER Director Peter Marks Discuss Vaccine Misinformation
January 8, 2024
Florida Rx Import Plan Approved By FDA, But Timing And Impact Remain Uncertain; Will First “SIP” Lead To Bigger Gulps?
January 5, 2024
FDA Advisory Committee Trends 2023: A Tale Two Halves — Fast Start Crashes To Halt; Uncertain Outlook Heading Into 2024
January 5, 2024
Prevision Policy Clips | Florida Rx Importation Plan Authorized By FDA: Approval Lasts For Two Years
January 5, 2024
Prevision Policy Clips | FDA’s Casgevy CRISPR Sickle Cell Gene Therapy Approval Included Four Pre-License Inspections
January 4, 2024
FDA’s Advice For Avoiding Clinical Holds In Gene/Cell Therapy Development: Pay Attention Early To Potency Assurance
January 3, 2024
Prevision Policy Clips | Geron’s Imetelstat For Myelodysplastic Syndrome To Get ICER Review In July
January 3, 2024
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