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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice.The EudraGMP system was launched in April 2007, for use by European Medicines Regulators.
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 European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
Drivers required to operate NDAS devices over a network are not shipped with operating systems. The devices are usually accompanied with client driver software for Microsoft Windows operating systems. Drivers for Linux-based operating systems (Linux distributions such as Fedora, Ubuntu or Debian) were originally available only from the ...
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
The Linux kernel has supported USB mass-storage devices since version 2.3.47 [3] (2001, backported to kernel 2.2.18 [4]).This support includes quirks and silicon/firmware bug workarounds as well as additional functionality for devices and controllers (vendor-enabled functions such as ATA command pass-through for ATA-USB bridges, used for S.M.A.R.T. or temperature monitoring, controlling the ...