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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.
A BLA is submitted after the investigational new drug (IND) phase, once the clinical investigations are completed. If the Form 356h is missing information, the FDA will reply within 74 days. [ 3 ] A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the ...
Variety of microbiological samples. A laboratory specimen is sometimes a biological specimen of a medical patient's tissue, fluids, or other samples used for laboratory analysis to assist in differential diagnosis or staging of a disease process. These specimens are often the most reliable method of diagnosis, depending on the ailment.
Canadian import duties is the amount of tax or tariff paid while importing goods into Canada. The Canada Border Services Agency collects the tariff on all imported goods. [ 1 ] The collection, administration and imposition of such duties is administered by the Customs Tariff Act .
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.
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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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