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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The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...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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![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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Sharan Murugan
- Dec 27, 2022
- 2 min
ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...
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![ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES](https://static.wixstatic.com/media/6516fb_17793b35da0046dc90a5295f61d03c14~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_17793b35da0046dc90a5295f61d03c14~mv2.jpg)
Sharan Murugan
- Sep 17, 2022
- 1 min
ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES
Recently the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the...
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