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Sharan Murugan
Jan 282 min read
USFDA Guidance: Navigating ANDA Submissions Latest Guidance on ANDA Amendments, Requests, and Labeling Revisions
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released two updated final guidances on 24 January...
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Sharan Murugan
Feb 13, 20221 min read
US FDA CDER Guidance Agenda -Calendar Year 2022
In 2022, CDER will publish new and revised guidances in its Guidance Agenda, which was released on January 31, 2022. The 2022 list...
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