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Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
Additional outcomes of this study are the values of precision and repeatability of REMS estimates, assessed using the Root Mean Square Coefficient of Variation (CV-RMS): precision has been evaluated as being 0.38% for lumbar spine and 0.32% for femoral neck, whereas the Least Significant Change (LSC) resulted in 1.05% and 0.88%, respectively ...
Processes are intended to support the objectives, according to the software level (A through D—Level E was outside the purview of DO-178B). Processes are described as abstract areas of work in DO-178B, and it is up to the planners of a real project to define and document the specifics of how a process will be carried out.
Conformance testing is applied in various industries where a product or service must meet specific quality and/or regulatory standards. This includes areas such as: [1] [3] [4] [7] [8] biocompatibility proofing; data and communications protocol engineering; document engineering; electronic and electrical engineering; medical procedure proofing
Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, [1] and version 3.0 was finalized on October 8 of the same year. [2] As of August 2016, the most current version is 3.2.2, released on July 16, 2008. [3] A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. [4]
[1] The iPLEDGE program was put into place a group formed by the companies that manufactured the drug at the time called the Isotretinoin Products Manufacturing Group (IPMG) under the direction of the Food and Drug Administration. The program launched on March 1, 2006, at the beginning of the annual meeting of the American Academy of Dermatology.
ODF 1.2 defines precisely the conformance needs. The specification defines conformance for documents, consumers, and producers, with two conformance classes called conforming and extended conforming. It further defines conforming text, spreadsheet, drawing, presentation, chart, image, formula and database front end documents.
A CoC is a producer's declaration that equipment, e.g. a car or motorcycles comply with the given approved type. This document contains information about the equipment and its producer's identification, type approval number, other technical specifications. The content of a CoC is defined by the European regulation (Amendment IX, Regulation 92/53).