отповикување

отповикување

Is the cancellation of a license and the withdrawal of the authorization to ship a biological product for sale, barter, or exchange in interstate commerce either at the request of the manufacturer or when grounds exist for the agency to initiate such an action.

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поништување, отповикување, укинување

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корекција

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"Correction" means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product and/or the promotional materials which ...

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Медико-биологические науки; Законодательное регулирование

The process of obtaining information concerning the other party's case. Methods of discovery are contained in Rule 16 of the Rules of Criminal Procedure, and Rules 26 through 37 ...

повлекување

Медико-биологические науки; Законодательное регулирование

A "recall" is a firm's removal or correction of a marketed product(s), including its labeling and/or promotional materials, that FDA considers to be in violation of the laws it ...

гаранција

Медико-биологические науки; Законодательное регулирование

A formal and signed agreement between buyers and sellers in which the latter verifies the goods he sells are not in violation of the FD&C Act when shipped.

меморандум за разбирање

Медико-биологические науки; Законодательное регулирование

This is a formal agreement with a state or local agency. The agreement does not involve a transfer of funds or a transfer of personal or real property (Agreements calling for ...

претходно известување

Медико-биологические науки; Законодательное регулирование

The FDA policy of notifying an individual or firm of a violation of the Federal FD&C Act, or other acts, when voluntary correction is an appropriate initial response to the ...