Cell and Gene Regulatory
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Gene Therapy For Mitochondrial Disease: A Guide To Emerging Regulation
3/1/2024
Learn how the FDA's expedited programs, along with the efforts of innovative companies, are paving the way for the development of effective gene therapies to address primary mitochondrial diseases.
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Response To FDA Black Box Warning
3/1/2024
The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.
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The Write Side Of AI: Helping Hands, Not Replacement Plans
3/1/2024
AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.
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Examining The 2024 Regulatory Landscape Of Cell And Gene Therapy
2/29/2024
The Cell and Gene Live 2024 Regulatory Outlook focused on key challenges, advancements, and regulatory strategies for navigating the evolving landscape of advanced therapies.
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Rare Disease Day 2024
2/29/2024
Today is Rare Disease Day 2024, a global initiative to raise awareness and generate support for everyone who is on a rare medical journey.
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Understanding Potency In Gene Therapy Development
2/28/2024
Explore the importance of understanding potency in cell and gene therapy (CGT) development and the challenges in developing potency assays for CGT products.
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Video Clips From Cell & Gene Live: 2024 Regulatory Outlook With FDA's Dr. Peter Marks And Dr. Nicole Verdun
2/27/2024
Our recent Cell & Gene Live, 2024 Regulatory Outlook With FDA's Drs. Peter Marks and Nicole Verdun, was a chock full of data and valuable information. I've broken down the full-length presentation into bite sized video clips that you can view at your convenience.
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FDA’s Updated Guidance On Human Genome Editing: New Implications & Remaining Questions
2/27/2024
On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.
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Digital Solution For Unified QA And QC Processes
2/27/2024
Explore the features and benefits of a digital solution that enables the optimization of batch release testing, stability study execution, and environmental monitoring.
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Streamlining Change Control To Increase Efficiency And Compliance
2/27/2024
Here, we outline a holistic approach to streamline the change control process, aiming to increase efficiency and compliance, improve quality, and shorten time-to-market.