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Sharan Murugan
Nov 272 min read
USFDA: Guidances to Advance Drug Development and Safety Assessments Advance Drug Development and Safety Assessments
The USFDA continues to innovate its regulatory landscape with the release of three important guidance earlier today (27 November, 2024)...
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Sharan Murugan
May 282 min read
USFDA Guidance: Platform Technology Designation Program for Drug Development
Today (29 May 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
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Sharan Murugan
Oct 10, 20232 min read
EMA Guidance: Qualification of Novel Methodologies for Drug Development, Guidance to Applicants
Recently the European Medicines Agency released an updated guidance on "Qualification of Novel Methodologies for Drug Development:...
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Sharan Murugan
May 18, 20232 min read
USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations
The United States Food & Drug Administration released two draft guidelines today (18-May-2023) "Pediatric Drug Development: Regulatory...
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Sharan Murugan
Apr 23, 20231 min read
USFDA Guidance: Animal Rule Developing Drugs for Prevention & Treatment "Acute Radiation Syndrome"
Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome:...
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Sharan Murugan
Apr 10, 20222 min read
ICH-Draft Guideline on Pediatric Extrapolation & FInal Guidance on Considerations for Clinical Study
As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline...
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