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Feb 171 min read

USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know

Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...

Feb 172 min read

EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD

Recently (14 February 2024) the European Medicines Agency released updated (annotated) guidance on "Guidance on the electronic submission...

Aug 22, 20221 min read

USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers

This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...

Aug 8, 20211 min read

Guidance’s on GMP for Investigational Products & for R&D facilities -WHO

World Health Organization (WHO) recently issued revised guidance to industry addressing good manufacturing practices (GMPs) for...