Cell and Gene Regulatory
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CMC And Regulatory Considerations For CRISPR Therapies
3/21/2024
This article explores the details of Chemistry, Manufacturing, and Controls and Critical Quality Attributes, which play an important role in gene editing.
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Groundbreaking Casgevy Approval Retrospective
3/21/2024
How is the approval of the US' first CRISPR therapy reshaping the landscape of CRISPR regulations and ongoing clinical trials?
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Accelerated Adventitious Virus Testing In Viral Vector Vaccines
3/21/2024
Implementing NGS technology for adventitious virus testing in viral vector vaccine development and manufacturing is crucial for ensuring safety. Gain insights for an optimized sequencing method.
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Navigating Regulatory Challenges For CGT Products In 2024 And Beyond
3/20/2024
The cell and gene therapy (CGT) regulatory landscape is complex and continuously evolving. Review expert insights based on recent FDA guidance as well as important considerations for CGT development.
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FDA Recommendations For Gene Therapy For Primary Mitochondrial Diseases
3/18/2024
Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).
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Overcoming Regulatory Challenges For A Complex Product
3/18/2024
A novel, in-house technology and complex combination product presented a number of regulatory challenges to overcome before FDA approval could be obtained.
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Navigate The Complexities Of CGTs With Regulatory And CMC Expertise
3/18/2024
Explore how strategic regulatory and CMC expertise helped guide a biopharmaceutical company’s regulatory and development strategy for a cell and gene therapy product.
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Expertly Navigating The Regulatory Landscape Together
3/18/2024
Cardinal Health Regulatory Sciences is a team of driven solutionists who expertly navigate the complex and evolving regulatory landscape, accelerating paths to market — and the critical therapies your patients need.
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CRISPR Therapeutic Regulatory Expertise And Support
3/13/2024
Explore regulatory support services that can help you successfully to navigate CRISPR-based therapeutic development and prepare you for a successful IND submission.
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A Structured Approach To Regulatory Information Management Vendor Selection
3/13/2024
Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.