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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...

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:...

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...

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Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome:...

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...