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EMA Guidance: Proposed Amendments - Variations Categories and Procedures
The European Medicines Agency (EMA) has proposed amendments to the European Commission's "Guidelines on Variations Categories and...

Sharan Murugan
Jun 15, 20242 min read
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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...

Sharan Murugan
Jan 28, 20242 min read
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