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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]
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]
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.
In addition, there are a small number of niche companies that focus specifically on the trial master file. Their services include process and quality consultancy, management and filing of trial master file content and provision of trial master file document management technology solutions (eTMFs).
If you need to take a COVID-19 test before free tests are available, you can buy over-the-counter test kits at most local pharmacies and drugstores. At-home tests typically cost about $10 to $25.
The AMA later published its first list of hospitals approved for residency training in 1927. [ 43 ] In 1927, Congress passed the Caustic Poison Act, lobbied for by the AMA, which required product labels to include warnings if they included lye or 10 other caustic chemicals.
CCHIT, in a collaboration with the MITRE Corporation, also developed an open-source program called Laika to test EHR software for compliance with federally named interoperability standards. In January 2014, Information Week reported that CCHIT would exit the EHR certification business. [6] On November 14, 2014, CCHIT ceased all operations. [7]