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![USFDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products](https://static.wixstatic.com/media/nsplsh_208f7f64e21d47a2a49fb251f4fc0f4e~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_208f7f64e21d47a2a49fb251f4fc0f4e~mv2.jpg)
Sharan Murugan
- Jan 31
- 2 min
USFDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products
On Monday (29 January 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation released two...
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![USFDA : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy Products](https://static.wixstatic.com/media/nsplsh_326679654c685565597067~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_326679654c685565597067~mv2.jpg)
Sharan Murugan
- Dec 30, 2023
- 2 min
USFDA : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy Products
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
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![USFDA Guidance: Manufacturing Changes & Comparability for CGT Products, Good Cause for Noncompliance](https://static.wixstatic.com/media/nsplsh_8ed893c8454c4a278b9c742d47db5d87~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_8ed893c8454c4a278b9c742d47db5d87~mv2.jpg)
Sharan Murugan
- Jul 15, 2023
- 2 min
USFDA Guidance: Manufacturing Changes & Comparability for CGT Products, Good Cause for Noncompliance
Last Week (13th & 14th July 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...
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![ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products](https://static.wixstatic.com/media/nsplsh_162feff45f5749d397c5464fa6ddcb22~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_162feff45f5749d397c5464fa6ddcb22~mv2.jpg)
Sharan Murugan
- Apr 29, 2023
- 2 min
ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 27th April, 2023 the United States Food & Drug Administration Center for Drug Evaluation and Research, and Center for Biologics...
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![USFDA Guidance: Multiple Biologics related Guidance - M10 Bioanalytical Method Validation](https://static.wixstatic.com/media/nsplsh_4a32384e6e2d4344624949~mv2_d_3000_3000_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_4a32384e6e2d4344624949~mv2_d_3000_3000_s_4_2.jpg)
Sharan Murugan
- Nov 4, 2022
- 1 min
USFDA Guidance: Multiple Biologics related Guidance - M10 Bioanalytical Method Validation
This week USFDAs Center for Biologics Evaluation and Research updated and released multiple guidances related to Gene therapy, Oncology,...
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