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Prevision Policy Clips | CBER Plans Cell And Gene Therapy FAQ Draft Guidance For 2024 Publication, Quick Turnaround Anticipated For Potency Assurance Guidance
January 30, 2024
FDA Revises Race And Ethnicity Data Collection Guidance But “Demographic Rule” Review May Lead To Future Changes; Diversity Action Plans Fall Outside Of Scope
January 29, 2024
Prevision Policy Clips | ODAC To Review Geron’s Imetelstat For MDS On March 14
January 29, 2024
Prevision Policy Clips | Biopharma Congress Is Only One Month Away: CBER’s Peter Marks and Celia Witten, OCE’s Richard Pazdur and Janet Woodcock
January 26, 2024
Pre-Term Birth Drug Development After Makena: New Endpoints Await Better Understanding Of Etiology; Modeling Approaches May Help
January 25, 2024
Senate Finance Drug Shortages White Paper Focuses On Generic Injectable Payment In Medicare; Outpatient Drug Ideas – Including Medicaid Rebate Changes – Appear Farther Away
January 25, 2024
Prevision Policy Clips | FDA Updates Remote Regulatory Assessment Q&A Guidance: FDORA Provisions
January 25, 2024
AI Neuroscience Tool For Depression Accepted By FDA Into ISTAND Program; Milestone In Rapidly Advancing Field – But Still Long Process Ahead
January 24, 2024
Prevision Policy Clips | Another CAR-T sBLA Advisory Committee: J&J/Legend’s Carvykti Will Go To ODAC For Label Expansion
January 24, 2024
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
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