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The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis
The information presented in this map reflects the results of hospice inspections provided by the Centers for Medicare and Medicaid Services (CMS), the hospice industry’s federal regulator, in response to a public records request. The time period covers Jan. 2, 2004, to Oct. 16, 2014.
A kardex (plural kardexes) is a genericised trademark for a medication administration record. [2] The term is common in Ireland and the United Kingdom.In the Philippines, the term is used to refer the old census charts of the charge nurse usually used during endorsement, in which index cards are used, but has been gradually been replaced by modern health data systems and pre-printed charts and ...
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
The MDA established a risk-based framework for the classification of medical devices and a regulatory pathway for medical devices to get to the market, created a regulatory pathway for medical device clinical trials, and established several post-market requirements including manufacturer registration and device listing with the FDA, good ...
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
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