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A New Approach to cGMP Inspections is Coming Soon. Our Contract Pharma Article Gives You a Preview.
Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.” The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA. Are you among the many […]