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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The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "...
Sharan Murugan
Feb 52 min read
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USFDA Draft Guidance: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision
The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...
Sharan Murugan
Jan 72 min read
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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...
Sharan Murugan
Aug 27, 20222 min read
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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...
Sharan Murugan
Jun 24, 20221 min read
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ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation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...
Sharan Murugan
Jun 18, 20222 min read
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