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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)Â released guidance "Charging for Investigational...

Sharan Murugan
Feb 17, 20241 min read
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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...

Sharan Murugan
Feb 17, 20242 min read
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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This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...

Sharan Murugan
Aug 22, 20221 min read
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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...

Sharan Murugan
Aug 8, 20211 min read
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