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Sharan Murugan
- Sep 11, 2023
- 1 min
TGA Guidance: Submitting data in the eCTD format
Recently (7th Spetember, 2023) Australia's Therapeutic Goods Administration (TGA) released revised and updated guidance "Submitting data...
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Sharan Murugan
- Sep 11, 2023
- 2 min
USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
Earlier today (11 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for...
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Sharan Murugan
- Sep 10, 2023
- 2 min
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
Recently on 05 September 2023, the United States Food & Drug Administration's Center for Drug Evaluation and , Research, Center for...
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Sharan Murugan
- Aug 22, 2023
- 2 min
Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines
Yesterday (21-August-2023) Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...
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Sharan Murugan
- Aug 17, 2023
- 1 min
USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors
The U.S. Food and Drug Administration (FDA) released its final guidance this Tuesday (15 August 2023), "Informed Consent: Guidelines for...
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