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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 ...
On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document [7] requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug ...
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 ).
Bitstream copying (or data backup) is a foundational operation often employed before many other practices, and facilitates establishing the redundancy of multiple storage locations: refreshing is the transportation of unchanging data, frequently between identical or functionally similar storage formats, while migration converts the format or ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Other mobile phone power supply and charging standards have been implemented in other parts of the world (e.g., Korea and China). Proposals for a global/industry-wide mobile phone charging solution have also been promoted by the International Telecommunication Union (ITU) and by industry organizations GSMA and OMTP. The ITU and the GSMA/OMTP ...
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
Paper data storage, e.g. punched cards, punched tapes (now obsolete) Examples of removable media that are standalone plug-and-play devices that carry their own reader hardwares include: USB flash drives [5] Portable storage devices. Dedicated external solid-state drives (SSD) Enclosured mass storage drives, i.e. modified hard disk drives (HDD ...