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Jun 152 min read

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...

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...