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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 California Department of Consumer Affairs (DCA) is a department within the California Business, Consumer Services, and Housing Agency. DCA's stated mission is to serve the interests of California's consumers by ensuring a standard of professionalism in key industries and promoting informed consumer practices.
California End of Life Option Act is a law enacted in June 2016 by the California State Legislature which allows terminally ill adult residents in the state of California to access medical aid in dying by self-administering lethal drugs, provided specific circumstances are met. [1]
The application responding to, i.e., performing, a request for services (orders) or producing an observation. The filler can also originate requests for services (new orders), add additional services to existing orders, replace existing orders, put an order on hold, discontinue an order, release a held order, or cancel existing orders.
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]
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Whilst the DIA doesn't have a formal, public and open standards effort in place to develop a formal, published standard, the use of the Reference Model is helping industry to standardize on the content of the trial master file, on the nomenclature for trial master file artifacts and on the taxonomy used.
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.