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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...

Sharan Murugan
Jan 31, 20242 min read
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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...

Sharan Murugan
Dec 30, 20232 min read
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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...

Sharan Murugan
Jul 15, 20232 min read
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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...

Sharan Murugan
Apr 29, 20232 min read
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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,...

Sharan Murugan
Nov 4, 20221 min read
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USFDA Guidance: Multiple Endpoints in Clinical Trials & Gene Therapy for Neurodegenerative Diseases
Earlier on 21 October 2022, the USFDA released two finalized guidances "Multiple Endpoints in Clinical Trials" and "Human Gene Therapy...

Sharan Murugan
Oct 23, 20221 min read
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FDA’s finalized “Interpreting Sameness” Gene Therapy Products Guidance
USFDA on 29 September 2021, finalized "Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations". This guidance...

Sharan Murugan
Oct 3, 20211 min read
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