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November 27, 2024

ANDAs: Impurities in Drug Substances

Docket Number: FDA-1998-D-0021 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides revised recommendations on what chemistry, manufacturing, and controls (CMC) […]
November 27, 2024

Other Meeting Options Related to Human Drugs

Patient group, Patient advocacy organization Patient Engagement, Cross-center Learn about FDA Patient Engagement Patient group, Patient advocacy organization Patient Engagement, Cross-center Learn about the Patient Engagement […]
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