Regulatory procedures manual

Regulatory procedures manual

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Food and Drug Administration. ... parts, accessories, or articles) is intended to be further processed by, or incorporated into a drug, biological product, device, food, food additive, color ... premarket reports (a new category of premarket application for reprocessed single-use devices), BLAs, certain supplements, and 510(k)s.

Title:Regulatory procedures manual
Author:United States. Food and Drug Administration. Office of Enforcement
Publisher: - 2004


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