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FDA Guidance for Industry: Size of Beads in Drug Products Labeled for Sprinkle
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM240243.pdf
Content:
This draft guidance provides sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research’s current thinking on appropriate size ranges for beads2 in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).
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