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FDA Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
Short Title:
Process Analytical Technology FDA Guidance
Origin/Publisher:
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070305.pdf
Document Type:
FDA Guidance for Industry
Content:
This guidance is intended to describe a regulatory framework that will encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.
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