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The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
Drug companies were required to show proof of the effectiveness of their drugs to advertise them in AMA's journal. [38] In 1906, the AMA established a Physician Masterfile designed to contain data on physicians in the United States as well as graduates of American medical schools and international graduates who are in the United States. Each ...
Winkler County, Texas. The Winkler County nurse whistleblower case was a series of legal proceedings in West Texas concerning the retaliation against two nurses who submitted an anonymous state medical board complaint against a physician in 2009. The case attracted national attention for its implications on whistleblowing by nurses.
Ameritox Ltd. was founded in 1996 in Midland, Texas as Universal Toxicology Laboratories (UTL), a federally certified drug testing facility and medical examiner toxicology laboratory. [1] UTL identified a growing need for a more detailed way of monitoring the use of long-term pain medications used by patients. The company became Ameritox Ltd ...
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).
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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The National Council for Prescription Drug Programs (NCPDP) is an American nonprofit standards development organization representing most sectors of the U.S. pharmacy services industry. It was founded in 1977 as the extension of a Drug Ad Hoc Committee that made recommendations for the U.S. National Drug Code (NDC).