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Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
The FDA has an easier burden to obtain both preliminary and permanent injunctive relief that does a private litigant, because the FDA is always acting in the public interest, and the injury sought to be prevented – violation of the laws designed to protect the public from harmful or misleading products – is presumed to be irreparable.
Regulation 1151/2012 on quality schemes for agricultural products and foodstuffs: defines "labelling" as "any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuff".
Foods that claim to be "healthy" on their packaging will soon be subject to a new set of labeling guidelines, part of an effort by the U.S. Food and Drug Administration to help educate consumers ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The 600 series covers biological products (e.g. vaccines, blood): 601 Licensing under section 351 of the Public Health Service Act; 606 et seq. cGMPs for human blood and blood products; The 700 series includes the limited regulations on cosmetics: 701 Labeling requirements; The 800 series are for medical devices: 803 Medical device reporting
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