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USFDA Guidance: Clinical Investigation Exclusivity Q&A and Responding to FDA Form 483 Observations
The U.S. Food and Drug Administration (FDA) has issued guidance documents to help pharmaceutical manufacturers understand regulatory expectations related to market exclusivity for drug products and responses to inspection findings following CGMP inspections . These guidances support transparency in regulatory processes and help industry ensure compliance with quality and development requirements. Guidance: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug
Sharan Murugan
2 days ago4 min read
ICH-USFDA Guidance: Non-Interventional Studies and Post-Approval Safety Reporting
This blog summarizes two important regulatory guidances from the U.S. Food and Drug Administration (FDA) that support pharmacovigilance and real-world evidence generation: M14: General Principles for Planning, Designing, Analyzing, and Reporting Non-Interventional Studies E2D(R1): Post-approval Safety Data – Definitions and Standards for Management and Reporting of Individual Case Safety Reports Together, these guidances provide a framework for how pharmaceutical companies ge
Sharan Murugan
2 days ago3 min read
USFDA Revised Rule: National Drug Code Format and Drug Label Barcode Requirements
The U.S. Food and Drug Administration (FDA) has issued a final rule titled “ Revising the National Drug Code Format and Drug Label Barcode Requirements .” This rule introduces a uniform 12-digit National Drug Code (NDC) format to standardize how drugs marketed in the United States are identified. The National Drug Code is an FDA standard used to uniquely identify drug products marketed in the U.S. Currently, the NDC assigned by FDA is a 10-digit number , and it may appear i
Sharan Murugan
2 days ago3 min read