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Sharan Murugan
Feb 52 min read
UK MHRA Draft Guideline: Individualised mRNA Cancer Immunotherapies
The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "...
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Sharan Murugan
Jan 72 min read
USFDA Draft Guidance: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision
The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...
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Sharan Murugan
Aug 27, 20222 min read
ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation
In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the...
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Sharan Murugan
Jun 24, 20221 min read
India MoH's - Draft Proposal for adding QR Codes for important SCHEDULE H2 Drugs
India's Ministry of Health and Human Welfare has released a draft proposal on 14th June, 2022 which suggests to add barcodes or quick...
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Sharan Murugan
Jun 18, 20222 min read
ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) It is commonly understood...
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