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Sharan Murugan
May 282 min
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
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
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
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Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome:...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
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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