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![Saudi's SFDA: Good Manufacturing Practice for Blood Establishments](https://static.wixstatic.com/media/nsplsh_a98ed4ba5c05420ab03437ddfde1e481~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_a98ed4ba5c05420ab03437ddfde1e481~mv2.webp)
Sharan Murugan
- Feb 7
- 2 min
Saudi's SFDA: Good Manufacturing Practice for Blood Establishments
Blood establishments play a crucial role in ensuring a safe and adequate supply of blood for transfusion and other medical purposes. To...
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![Australia TGA: eCTD AU module 1 and regional information](https://static.wixstatic.com/media/6516fb_8ef3af1af6634cf39752ce24036f40a5~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_8ef3af1af6634cf39752ce24036f40a5~mv2.webp)
Sharan Murugan
- Jan 31
- 1 min
Australia TGA: eCTD AU module 1 and regional information
Australia's Therapeutic Goods Administration (TGA) released updated guidance "eCTD AU module 1 and regional information" on 30 January...
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![USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products](https://static.wixstatic.com/media/6516fb_34258262947447059a4577539542a42f~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_34258262947447059a4577539542a42f~mv2.webp)
Sharan Murugan
- Jan 31
- 1 min
USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...
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![USFDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products](https://static.wixstatic.com/media/nsplsh_208f7f64e21d47a2a49fb251f4fc0f4e~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_208f7f64e21d47a2a49fb251f4fc0f4e~mv2.webp)
Sharan Murugan
- Jan 31
- 2 min
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...
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![USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers](https://static.wixstatic.com/media/nsplsh_f2895b9f7aea4be79b1b1833a2bcb049~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_f2895b9f7aea4be79b1b1833a2bcb049~mv2.webp)
Sharan Murugan
- Jan 28
- 2 min
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...
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