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FDA Guidance for Industry:Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline

Origin/Publisher:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609205.pdf

Content:
This guideline applies to pharmaceutical drug substances (i.e., active pharmaceutical ingredients) and pharmaceutical drug products, including marketed chemical, and biotechnological/biological products.

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