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USFDA Guidance: Reporting Amount of Listed Drugs and Biological Product and Key Information and Facilitating Understanding in Informed Consent Guidance
Earlier this week (26 & 29 February 2024) the the U.S. Food and Drug Administration (FDA)Â released two guidances "Reporting Amount of...

Sharan Murugan
Mar 2, 20242 min read
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USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors
The U.S. Food and Drug Administration (FDA) released its final guidance this Tuesday (15 August 2023), "Informed Consent: Guidelines for...

Sharan Murugan
Aug 17, 20231 min read
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