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![ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines](https://static.wixstatic.com/media/nsplsh_b58e90a363cf472d88b6f4f10478df62~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_b58e90a363cf472d88b6f4f10478df62~mv2.jpg)
Sharan Murugan
- May 31
- 2 min
ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...
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![ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development](https://static.wixstatic.com/media/6516fb_f6c894b7d18c4ee688acc9bb369884e6~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_f6c894b7d18c4ee688acc9bb369884e6~mv2.jpg)
Sharan Murugan
- Mar 13
- 1 min
ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development
Last week the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Office of Regulatory Policy, and the...
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![USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities](https://static.wixstatic.com/media/nsplsh_91b0e436b245496691c8b344a08d2d50~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_91b0e436b245496691c8b344a08d2d50~mv2.jpg)
Sharan Murugan
- Jul 24, 2023
- 2 min
USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities
Earlier today (25 June, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...
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![USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials](https://static.wixstatic.com/media/nsplsh_d615b4690010441ca65aa075324e8783~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_d615b4690010441ca65aa075324e8783~mv2.jpg)
Sharan Murugan
- Jun 6, 2023
- 1 min
USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...
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![ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management](https://static.wixstatic.com/media/6516fb_1aa5ba9c977349c1a412a73dd0f8e85e~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_1aa5ba9c977349c1a412a73dd0f8e85e~mv2.jpg)
Sharan Murugan
- May 4, 2023
- 1 min
ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...
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