Federal Food, Drug, and Cosmetic Act (original) (raw)

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Le Federal Food, Drug and Cosmetic Act est une loi fédérale américaine, signée en 1938 par le président Roosevelt, à la suite du scandale de l'année précédente lors duquel une centaine de personnes étaient décédées à la suite de l'ingestion de l'élixir sulfanilamide, médicament rendu toxique par la présence de diéthylène glycol. Venant après le Pure Food and Drug Act de 1906, qui mènera à la création de la Food and Drug Administration (FDA), cette nouvelle loi vient renforcer les pouvoirs de l'administration fédérale et en particulier de la FDA en matière d'autorisation de mise sur le marché (AMM) des médicaments et produits cosmétiques.

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dbo:abstract القانون الفدرالي الأمريكي للغذاء والدواء ومواد التجميل Federal Food, Drug, and Cosmetic Act ، واختصاره (FFDCA أو FDCA أو FD & C) وهو مجموعة من القوانين التي أقرها الكونغرس في عام 1938 ويعطي سلطة لإدارة الغذاء والدواء الأمريكية (FDA) للإشراف على سلامة الغذاء والأدوية، ومستحضرات التجميل. كان المشرع الرئيسي لهذا القانون هو رويال س. كوبلاند، وهو عضو في مجلس الشيوخ من الولايات المتحدة من نيويورك لمدة ثلاث سنوات. في عام 1968، أضيفت أحكام الالكترونية المنتج الإشعاع تحكم إلى القانون. أيضًا في ذلك العام شكلت إدارة الغذاء والدواء (FDA) تنفيذ دراسة كفاءة الدواء (DESI) لدمجها في لوائح القانون والتوصيات من الأكاديمية الوطنية للعلوم التحقيق في فعالية الأدوية المسوقة سابقا. تم تعديل القانون عدة مرات، كان آخرها لإضافة متطلبات حول الاستعدادات للإرهاب البيولوجي. تأثر إدخال هذا القانون بوفاة أكثر من 100 مريض بسبب دواء السلفانيلاميد حيث تم استخدام داي إيثيلين جلايكول لإذابة الدواء وصنع سائلًا (انظر كارثة إكسير سلفانيلاميد). وقد حلت محل قانون الأغذية والأغذية النقية السابق لعام 1906. (ar) Der Federal Food, Drug, and Cosmetic Act (abgekürzt FFDCA, FDCA oder FD&C) umfasst eine Reihe gesetzlicher Regelungen, die die Food and Drug Administration dazu ermächtigen, die Sicherheit von Lebensmitteln, Arzneimitteln, medizinischen Produkten und Kosmetik zu überwachen und wurde 1938 vom US-Kongress verabschiedet. Hauptautor des Gesetzes war Royal S. Copeland, ein Senator aus New York. 1968 wurden Bestimmungen zur Kontrolle der Strahlung elektronischer Produkte in den FD&C Act aufgenommen. Das Gesetz wurde bereits mehrfach geändert. Grund für den Erlass des Gesetzes war der Tod von über 100 Patienten aufgrund eines Sulfanilamid-Medikamentes, für das Diethylenglycol als Lösungsmittel genutzt wurde (siehe Sulfanilamid-Katastrophe). Es ersetzte den Pure Food and Drug Act aus dem Jahr 1906. (de) The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was used to dissolve the drug and make a liquid form. It replaced the earlier Pure Food and Drug Act of 1906. (en) La Ley Federal de Alimentos, Medicamentos y Cosméticos de Estados Unidos (en inglés, The United States Federal Food, Drug, and Cosmetic Act, abreviada como FFDCA, FDCA o FD & C) es un conjunto de leyes aprobadas por el Congreso de los Estados Unidos en 1938, que dio autoridad a la Agencia de Medicamentos y Alimentación (Food and Drug Administration, FDA) para supervisar la seguridad de los alimentos, medicamentos y cosméticos. El autor principal de esta ley fue , quien fue senador por el estado de Nueva York durante tres legislaturas.​ En 1968, se agregaron ciertas disposiciones sobre el control de la radiación de los productos electrónicos. También en ese año la FDA creó el Drug Efficacy Study Implementation —DESI— (Implementación del Estudio de la Eficacia de los Medicamentos) para incorporar a los reglamentos las recomendaciones de una investigación de la Academia Nacional de Ciencias de Estados Unidos acerca de la eficacia de los medicamentos que ya estaban disponibles en el mercado.​ La ley ha sido modificada muchas veces; la más reciente, para añadir requisitos sobre las preparaciones de bioterrorismo. La creación de esta ley se vio influida por la muerte de más de 100 pacientes provocada por el denominado Elíxir sulfanilamida, un medicamento a base de sulfamida que era disuelto en dietilenglicol para presentarlo en forma líquida.​​ Vino a subsituir la Ley de Pureza de Alimentos y Medicamentos de 1906. (es) Le Federal Food, Drug and Cosmetic Act est une loi fédérale américaine, signée en 1938 par le président Roosevelt, à la suite du scandale de l'année précédente lors duquel une centaine de personnes étaient décédées à la suite de l'ingestion de l'élixir sulfanilamide, médicament rendu toxique par la présence de diéthylène glycol. Venant après le Pure Food and Drug Act de 1906, qui mènera à la création de la Food and Drug Administration (FDA), cette nouvelle loi vient renforcer les pouvoirs de l'administration fédérale et en particulier de la FDA en matière d'autorisation de mise sur le marché (AMM) des médicaments et produits cosmétiques. (fr) 連邦食品・医薬品・化粧品法(れんぽうしょくひんいやくひんけしょうひんほう、英語: Federal Food, Drug, and Cosmetic Act、略称: FFDCA、FDCA、FD&C)は、アメリカ食品医薬品局(FDA)に、食の安全性、薬品、化粧品に関する権限を与える法律である。1938年にアメリカ合衆国議会で可決された。この法律の主な著者はニューヨークから上院議員に三選したRoyal S. Copelandである。1968年には、電子製品からの放射線の管理条項が追加された。またこの年にFDAは、米国科学アカデミーによるFD&C法以前の市販医薬品の有効性についての勧告を組み込むために(DESI)を作成した。この法律は何度も改正されており、最近ではバイオテロに関する条項の準備が要求されている。 (ja) Federalna ustawa o żywności, lekach i kosmetykach (ang. Federal Food, Drug, and Cosmetic Act, FFDCA, FDCA, FD&C) – akt prawny uchwalony przez Kongres Stanów Zjednoczonych w 1938 roku, dający Agencji Żywności i Leków prawo nadzorowania bezpieczeństwa żywności, leków i kosmetyków. (pl) Lei Federal de Alimentos, Medicamentos e Cosméticos dos Estados Unidos (em inglês The United States Federal Food, Drug, and Cosmetic Act abreviado como FFDCA, FDCA ou FD&C), é um conjunto de lei aprovadas pelo Congresso em 1938, que deu autoridade à Food and Drug Administration (FDA) para supervisionar a segurança dos alimentos, medicamentos e cosméticos. O autor principal desta lei foi , que foi senador pelo estado de Nova York por três mandatos. (pt) 美国联邦食品、药品和化妆品法案(常缩写为FFDCA,FDCA,或FD&C)是美国国会在1938年通过的一系列法案的总称,赋予美国食品药品监督管理局(FDA)监督监管食品安全、药品、及化妆品的权力。该法案主要是由写成,其为一三年期的纽约州参议员。该法案通过后又历经多次修改。 催生该法案的主要原因之一是因为一种磺胺药物中所使用的溶剂二甘醇导致100多名病人死亡。这部法案诞生后取代了1906年通过的。 (zh)
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dbp:acronym FFDCA, FD&C Act (en)
dbp:actsRepealed dbr:Pure_Food_and_Drug_Act
dbp:amendments *1951 Food, Drug, and Cosmetics Act Amendments, PL 82–215, 65 Stat 648 *1962 Food, Drug, and Cosmetics Act Amendments, PL 87–781, 76 Stat 780 *Fair Packaging and Labeling Act, PL 89–755, 80 Stat 1296 *Medical Device Regulation Act, PL 94–295, 90 Stat 539 *Radiation Control for Safety and Health Act, PL 90-602, 82 Stat 1173 *Drug Price Competition and Patent Term Restoration Act of 1984, PL 98-471, 98 Stat 1585 *Nutrition Labeling and Education Act , PL 101-535, 104 Stat 2353 *Safe Medical Device Amendments of 1990, PL 101-629, 104 Stat 4511 *Food and Drug Administration Revitalization Act , PL 101-635, 104 Stat 4583 *Dietary Supplement Health and Education Act , PL 103-417, 108 Stat 4332 *Food Quality Protection Act of 1996 *Food and Drug Administration Modernization Act of 1997, PL 105-115, 111 Stat 2296 *Food and Drug Administration Amendments Act of 2007, PL 110-85, 121 Stat 823 (en)
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dbp:introducedby Royal Copeland (en)
dbp:introduceddate 1937-01-06 (xsd:date)
dbp:introducedin Senate (en)
dbp:longtitle To prohibit the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, and for other purposes. (en)
dbp:passedbody House (en) Senate (en) House with amendment (en)
dbp:passeddate 1937-03-09 (xsd:date) 1938-06-01 (xsd:date) 1938-06-10 (xsd:date) 1938-06-13 (xsd:date)
dbp:passedvote voice (en)
dbp:publicLawUrl https://research.archives.gov/description/299847
dbp:sectionsCreated § 301 et seq. (en)
dbp:shorttitle Federal Food, Drug, and Cosmetic Act (en)
dbp:signeddate 1938-06-25 (xsd:date)
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dbp:titleAmended 21 (xsd:integer)
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rdfs:comment Le Federal Food, Drug and Cosmetic Act est une loi fédérale américaine, signée en 1938 par le président Roosevelt, à la suite du scandale de l'année précédente lors duquel une centaine de personnes étaient décédées à la suite de l'ingestion de l'élixir sulfanilamide, médicament rendu toxique par la présence de diéthylène glycol. Venant après le Pure Food and Drug Act de 1906, qui mènera à la création de la Food and Drug Administration (FDA), cette nouvelle loi vient renforcer les pouvoirs de l'administration fédérale et en particulier de la FDA en matière d'autorisation de mise sur le marché (AMM) des médicaments et produits cosmétiques. (fr) 連邦食品・医薬品・化粧品法(れんぽうしょくひんいやくひんけしょうひんほう、英語: Federal Food, Drug, and Cosmetic Act、略称: FFDCA、FDCA、FD&C)は、アメリカ食品医薬品局(FDA)に、食の安全性、薬品、化粧品に関する権限を与える法律である。1938年にアメリカ合衆国議会で可決された。この法律の主な著者はニューヨークから上院議員に三選したRoyal S. Copelandである。1968年には、電子製品からの放射線の管理条項が追加された。またこの年にFDAは、米国科学アカデミーによるFD&C法以前の市販医薬品の有効性についての勧告を組み込むために(DESI)を作成した。この法律は何度も改正されており、最近ではバイオテロに関する条項の準備が要求されている。 (ja) Federalna ustawa o żywności, lekach i kosmetykach (ang. Federal Food, Drug, and Cosmetic Act, FFDCA, FDCA, FD&C) – akt prawny uchwalony przez Kongres Stanów Zjednoczonych w 1938 roku, dający Agencji Żywności i Leków prawo nadzorowania bezpieczeństwa żywności, leków i kosmetyków. (pl) Lei Federal de Alimentos, Medicamentos e Cosméticos dos Estados Unidos (em inglês The United States Federal Food, Drug, and Cosmetic Act abreviado como FFDCA, FDCA ou FD&C), é um conjunto de lei aprovadas pelo Congresso em 1938, que deu autoridade à Food and Drug Administration (FDA) para supervisionar a segurança dos alimentos, medicamentos e cosméticos. O autor principal desta lei foi , que foi senador pelo estado de Nova York por três mandatos. (pt) 美国联邦食品、药品和化妆品法案(常缩写为FFDCA,FDCA,或FD&C)是美国国会在1938年通过的一系列法案的总称,赋予美国食品药品监督管理局(FDA)监督监管食品安全、药品、及化妆品的权力。该法案主要是由写成,其为一三年期的纽约州参议员。该法案通过后又历经多次修改。 催生该法案的主要原因之一是因为一种磺胺药物中所使用的溶剂二甘醇导致100多名病人死亡。这部法案诞生后取代了1906年通过的。 (zh) القانون الفدرالي الأمريكي للغذاء والدواء ومواد التجميل Federal Food, Drug, and Cosmetic Act ، واختصاره (FFDCA أو FDCA أو FD & C) وهو مجموعة من القوانين التي أقرها الكونغرس في عام 1938 ويعطي سلطة لإدارة الغذاء والدواء الأمريكية (FDA) للإشراف على سلامة الغذاء والأدوية، ومستحضرات التجميل. (ar) Der Federal Food, Drug, and Cosmetic Act (abgekürzt FFDCA, FDCA oder FD&C) umfasst eine Reihe gesetzlicher Regelungen, die die Food and Drug Administration dazu ermächtigen, die Sicherheit von Lebensmitteln, Arzneimitteln, medizinischen Produkten und Kosmetik zu überwachen und wurde 1938 vom US-Kongress verabschiedet. Hauptautor des Gesetzes war Royal S. Copeland, ein Senator aus New York. 1968 wurden Bestimmungen zur Kontrolle der Strahlung elektronischer Produkte in den FD&C Act aufgenommen. Das Gesetz wurde bereits mehrfach geändert. (de) The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparat (en) La Ley Federal de Alimentos, Medicamentos y Cosméticos de Estados Unidos (en inglés, The United States Federal Food, Drug, and Cosmetic Act, abreviada como FFDCA, FDCA o FD & C) es un conjunto de leyes aprobadas por el Congreso de los Estados Unidos en 1938, que dio autoridad a la Agencia de Medicamentos y Alimentación (Food and Drug Administration, FDA) para supervisar la seguridad de los alimentos, medicamentos y cosméticos. El autor principal de esta ley fue , quien fue senador por el estado de Nueva York durante tres legislaturas.​ En 1968, se agregaron ciertas disposiciones sobre el control de la radiación de los productos electrónicos. También en ese año la FDA creó el Drug Efficacy Study Implementation —DESI— (Implementación del Estudio de la Eficacia de los Medicamentos) para incor (es)
rdfs:label Federal Food, Drug, and Cosmetic Act (en) قانون الغذاء والدواء ومواد التجميل (ar) Federal Food, Drug, and Cosmetic Act (de) Ley Federal de Alimentos, Medicamentos y Cosméticos de Estados Unidos (es) Federal Food, Drug and Cosmetic Act (fr) 連邦食品・医薬品・化粧品法 (ja) Federalna ustawa o żywności, lekach i kosmetykach (pl) Lei Federal de Alimentos, Medicamentos e Cosméticos dos Estados Unidos (pt) 联邦食品、药品和化妆品法案 (zh)
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