INSIGHTS ON CELL & GENE REGULATORY ISSUES
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Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities
The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.
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Audit Trail Compliance And What To Look For In Mitigation Software
In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.
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Mitigating Risk With Ex-US Clinical Trials
Gain insight into why certain regions offer strategic advantages, from regulatory flexibility to faster enrollment, and how to effectively integrate them into your development strategy.
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Accelerating Trial Start-Up: CRO Best Practices For 2025
In 2025, accelerating clinical trial start-up is critical, and Clinical Research Organizations (CROs) are applying innovative approaches to drive efficiency in site activation, enrollment, and regulatory approvals.
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Live Biotherapeutic Products: Unique Quality, Manufacturing And Nonclinical Considerations For Clinical Trial Entry
Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.
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Advancing Gene Delivery: LNPs, Adenovirus, Lentivirus, And More | Audience Q&A
In this segment of Cell & Gene Live, Advancing Gene Delivery: LNPs, Adenovirus, Lentivirus, And More, Karen Kozarsky, Ph.D., President of Vector BioPartners breaks down the growing role of lipid nanoparticles (LNPs) in gene therapy.
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Accelerate FDA Approval With Fast Track Designation
Learn how Fast Track Designation streamlines the FDA review process and offers faster approval for serious diseases or life-threatening conditions.
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7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies
The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.
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CMC Strategies For Cell And Gene Therapy Development
The regulatory environment for cell and gene therapies (CGTs) is evolving rapidly, requiring sponsors to adopt a more strategic, integrated development approach.
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Planning Your IND: When And Why To Engage The FDA
This presentation explores how and when to initiate IND activities, highlighting that sponsors can strategically open an IND to access FDA guidance and enable U.S. clinical trials.