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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
Nov 8, 20221 min read
USFDA Guidance: Sameness Evaluations in an ANDA — Active Ingredients
Earlier today (November 8, 2022) USFDAs Center for Drug Evaluation and Research, Office of Generic Drugs released a Draft guideline on...
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Sharan Murugan
Feb 6, 20221 min read
Guidance on Revising ANDA Labeling Following Revision of the RLD Labeling
This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling...
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