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The Indonesian Food and Drug Authority (Indonesian: Badan Pengawas Obat dan Makanan, lit. 'Food and Drug Supervisory Agency'), Badan POM/BPOM, or Indonesian FDA is a government agency of Indonesia responsible for protecting public health through the control and supervision of prescription and over-the-counter pharmaceutical drugs (medication), vaccines, biopharmaceuticals, dietary supplements ...
Enlargement of KBBI was established as a national policy, with the budget support of 14 billion Indonesian rupiah. [4] To achieve the goal, the Agency engaged a team of 165 annotators, 46 editors and 15 validators, and sought assistance from Oxford University Press and Lexical Computing .
The Fast Healthcare Interoperability Resources (FHIR, / f aɪər /, like fire) standard is a set of rules and specifications for the secure exchange of electronic health care data.
The Pharmaceuticals and Medical Devices Agency (独立行政法人医薬品医療機器総合機構, Dokuritsu-gyōsei hōjin iyakuhin-iryō-kiki-sōgō-kikō) (PhMDA ...
Saudi Food and Drug Authority (SFDA) (Arabic: الهيئة العامة للغذاء والدواء) is an independent body for the Kingdom of Saudi Arabia that aims to ensure food and drug safety for the nation.
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
In February 2007, the U.S. Food and Drug Administration (FDA) cleared the MammaPrint test for use in the U.S. for lymph node negative breast cancer patients of all ages, ER negative or ER positive, with tumors of less than 5 cm. [19] MammaPrint can be considered as a part of standard of care disease management for early stage breast cancer and ...
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...