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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]
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.
Board certification is also used in the field of pharmacy, where a pharmacist can be recognized in specialized areas of advanced pharmacy practice after fulfilling eligibility requirements and passing a certification examination by the Board of Pharmacy Specialties [3] or the National Board of Medication Therapy Management. [4]
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.
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.
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.
Shenandoah National Park, Virginia. Seventy-five miles from Washington D.C., and about 100 miles from Richmond, Virginia, Shenandoah National Park is a leisurely road trip to take in the state's ...