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The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Laboratory Corporation of America Holdings (Labcorp), headquartered in Burlington, North Carolina, provides laboratory services used for diagnosis and healthcare decisions. [1] It operates one of the largest clinical laboratory networks in the world and has operations in over 100 countries; although its operations are primarily in the U.S. [ 1 ]
In the case of a tested product/material/sample, the recipient of the COA will be the entity that ordered the analysis or mandated the test via regulation, as with cannabis testing. If a regulatory body mandated the test, they will designate how the results should be delivered, whether physically or electronically.
The Quality Samples Program (QSP) is a pilot program, started in 2000 and administered by the Foreign Agricultural Service (FAS), that utilizes Commodity Credit Corporation (CCC) funds to reimburse U.S. agricultural trade organizations for the cost of providing small samples of U.S. products to potential importers located in overseas emerging markets.
The accuracy of an analytical procedure shall be established across its range. 4.7. Precision: The precision of an analytical procedure expresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. 4.8.
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Article 58 requires that "the sponsor and investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial." This requirement defines a minimum retention period across the EU for all clinical trial master files, irrespective of whether the data subsequently supports a marketing ...
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