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<article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" article-type="research-article" dtd-version="1.2" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">RUDN Journal of Law</journal-id><journal-title-group><journal-title xml:lang="en">RUDN Journal of Law</journal-title><trans-title-group xml:lang="ru"><trans-title>Вестник Российского университета дружбы народов. Серия: Юридические науки</trans-title></trans-title-group></journal-title-group><issn publication-format="print">2313-2337</issn><issn publication-format="electronic">2408-9001</issn><publisher><publisher-name xml:lang="en">Peoples’ Friendship University of Russia named after Patrice Lumumba (RUDN University)</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">20772</article-id><article-id pub-id-type="doi">10.22363/2313-2337-2018-22-3-329-345</article-id><article-categories><subj-group subj-group-type="toc-heading" xml:lang="en"><subject>LAW AND DIGITAL TECHNOLOGIES</subject></subj-group><subj-group subj-group-type="toc-heading" xml:lang="ru"><subject>ПРАВО И ЦИФРОВЫЕ ТЕХНОЛОГИИ</subject></subj-group><subj-group subj-group-type="article-type"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title xml:lang="en">State Control of the Interpretation of Genomic Studies and Medical Applications in the United States of America</article-title><trans-title-group xml:lang="ru"><trans-title>Государственный контроль интерпретации геномных исследований и медицинских приложений в Соединенных Штатах Америки</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Sakhipgareeva</surname><given-names>Anzhelika R</given-names></name><name xml:lang="ru"><surname>Сахипгареева</surname><given-names>Анжелика Рафаэлевна</given-names></name></name-alternatives><bio xml:lang="en"><p>PhD student, Department of Administrative Law and Procedure of Kutafin Moscow State Law University (MSAL)</p></bio><bio xml:lang="ru"><p>аспирант кафедры административного права и процесса Московского государственного юридического университета имени О. Е. Кутафина (МГЮА)</p></bio><email>sar.3472@yandex.ru</email><xref ref-type="aff" rid="aff1"/></contrib></contrib-group><aff-alternatives id="aff1"><aff><institution xml:lang="en">O.E. Kutafin Moscow State Juridical University (MSJU)</institution></aff><aff><institution xml:lang="ru">Московский государственный юридический университет имени О.Е. Кутафина (МГЮА)</institution></aff></aff-alternatives><pub-date date-type="pub" iso-8601-date="2018-12-15" publication-format="electronic"><day>15</day><month>12</month><year>2018</year></pub-date><volume>22</volume><issue>3</issue><issue-title xml:lang="en">VOL 22, NO3 (2018)</issue-title><issue-title xml:lang="ru">ТОМ 22, №3 (2018)</issue-title><fpage>329</fpage><lpage>345</lpage><history><date date-type="received" iso-8601-date="2019-03-19"><day>19</day><month>03</month><year>2019</year></date></history><permissions><copyright-statement xml:lang="en">Copyright ©; 2018, Sakhipgareeva A.R.</copyright-statement><copyright-statement xml:lang="ru">Copyright ©; 2018, Сахипгареева А.Р.</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="en">Sakhipgareeva A.R.</copyright-holder><copyright-holder xml:lang="ru">Сахипгареева А.Р.</copyright-holder><ali:free_to_read xmlns:ali="http://www.niso.org/schemas/ali/1.0/"/><license><ali:license_ref xmlns:ali="http://www.niso.org/schemas/ali/1.0/">http://creativecommons.org/licenses/by/4.0</ali:license_ref></license></permissions><self-uri xlink:href="https://journals.rudn.ru/law/article/view/20772">https://journals.rudn.ru/law/article/view/20772</self-uri><abstract xml:lang="en"><p>This Article is devoted to the theoretical ideas about the features of state control in genomic research and medical applications in the United States of America. The purpose of this study is to examine the legal aspects of the interpretation of genomic research and medical applications in the United States of America, to study the features of the state control of medical applications, as well as companies providing services in the field of genomic research. As a result of the review, the author provides with the information about several features of the state control of the US Food and drug administration (FDA), degree of regulatory intervention in the activities of genetic research companies, identify classification of medical applications apps.</p></abstract><trans-abstract xml:lang="ru"><p>Статья посвящена изучению теоретических разработок в области государственного контроля геномных исследований и медицинских приложений в Соединенных Штатах Америки. Автор рассматривает юридические аспекты данных разработок, особенности процедуры государственного контроля геномных исследований и медицинских приложений, а также деятельность юридических лиц, предоставляющих услуги в области геномных исследований. В рамках исследования выявляются ключевые характеристики процедуры государственного контроля данных исследований со стороны Управления по надзору за качеством пищевых продуктов и медикаментов США. Кроме того, отображается степень влияния органа-регулятора на деятельность компаний, занимающихся генетическими исследованиями. В завершающей части статьи автор предлагает собственную классификацию медицинских приложений.</p></trans-abstract><kwd-group xml:lang="en"><kwd>government</kwd><kwd>legitimacy</kwd><kwd>regulation</kwd><kwd>genome research review bodies</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>государство</kwd><kwd>легальность</kwd><kwd>регулирование</kwd><kwd>геномные исследования, органы контроля</kwd></kwd-group><funding-group/></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>Bloss, C. S., Schork, N. J. &amp; Topol, E. J. N. (2011) Engl. J. Med. 364,.</mixed-citation></ref><ref id="B2"><label>2.</label><mixed-citation>Clement, P.D., Tribe L.H. (2015) Laboratory testing services, as the practice of medicine, cannot be regulated as medical devices. Washington, DC: American Clinical Laboratory Association.</mixed-citation></ref><ref id="B3"><label>3.</label><mixed-citation>ClinGen and Genetic Testing. 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