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In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
The American Medical Association (AMA) Physician Professional Data (formerly known as the AMA Physician Masterfile) includes current and historical data on all physicians, including AMA members and nonmembers, and graduates of foreign medical schools who reside in the United States and who have met the educational and credentialing requirements necessary for recognition as physicians. [1]
Bar code medication administration (BCMA) is a barcode system designed by Glenna Sue Kinnick to prevent medication errors in healthcare settings and to improve the quality and safety of medication administration. The overall goals of BCMA are to improve accuracy, prevent errors, and generate online records of medication administration.
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Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Article 57 of the Regulation requires that the TMF "shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated", confirming that the trial master file should be maintained contemporaneously.
State regulators faulted two hospitals in Southern California for medication errors that put patients at risk, including one who suffered a brain bleed after receiving repeated doses of blood thinner.