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USFDA Guidance: Alternative Tools for Facility Assessments in Pending Applications
The U.S. Food and Drug Administration (FDA) has issued a final guidance on 11th September 2025 titled “ Alternative Tools: Assessing Drug...

Sharan Murugan
Sep 142 min read
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USFDA Guidance: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
The U.S. Food and Drug Administration (FDA)Â has released an updated guidance " ANDAs: Pre-Submission Facility Correspondence Related to...

Sharan Murugan
Jun 132 min read
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USFDA Guide: Review of DMF in Advance of Certain ANDA Submissions & Facility Readiness-Under GDUFA
Earlier today (03 October 2022) USFDA released two finalized guidelines "Review of Drug Master Files in Advance of Certain ANDA...

Sharan Murugan
Oct 3, 20221 min read
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