Matches in DBpedia 2016-04 for { <http://dbpedia.org/resource/Generally_recognized_as_safe_and_effective> ?p ?o }
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- Generally_recognized_as_safe_and_effective abstract "Generally recognized as safe and effective (abbreviated as GRASE, GRAS/E, or GRAS/GRAE) is designation for certain old drugs that do not require prior approval from the U.S. Food and Drug Administration in order to enter the United States marketplace because they are generally recognized as safe and effective by medical professionals. The Federal Food, Drug, and Cosmetic Act defines a \"new drug\", which requires prior approval, as any drug \"the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.\"It is important to emphasize that \"safe and effective\" is always conditional on following the directions. For example, aspirin can be lethal when taken in large amounts but is approved to be GRAS/E by FDA for over-the-counter use as directed.FDA has acknowledged the possible existence of drugs that could be considered GRAS/E that they have not found to be GRAS/E yet. As FDA stated in its 2006 Guidance on Marketed Unapproved drugs: \"A product would not be considered a new drug if it is generally recognized as safe and effective (GRAS/GRAE) and has been used to a material extent and for a material time… As mentioned above, the Agency believes it is not likely that any currently marketed prescription drug product is grandfathered or is otherwise not a new drug. However, the Agency recognizes that it is at least theoretically possible.\"".
- Generally_recognized_as_safe_and_effective wikiPageID "12204550".
- Generally_recognized_as_safe_and_effective wikiPageLength "2530".
- Generally_recognized_as_safe_and_effective wikiPageOutDegree "10".
- Generally_recognized_as_safe_and_effective wikiPageRevisionID "614648442".
- Generally_recognized_as_safe_and_effective wikiPageWikiLink Aspirin.
- Generally_recognized_as_safe_and_effective wikiPageWikiLink Category:Legal_terms.
- Generally_recognized_as_safe_and_effective wikiPageWikiLink Federal_Food,_Drug,_and_Cosmetic_Act.
- Generally_recognized_as_safe_and_effective wikiPageWikiLink Food_and_Drug_Administration.
- Generally_recognized_as_safe_and_effective wikiPageWikiLink Generally_recognized_as_safe.
- Generally_recognized_as_safe_and_effective wikiPageWikiLink Grandfather_clause.
- Generally_recognized_as_safe_and_effective wikiPageWikiLink List_of_drug_interactions.
- Generally_recognized_as_safe_and_effective wikiPageWikiLink Over-the-counter_drug.
- Generally_recognized_as_safe_and_effective wikiPageWikiLink United_States.
- Generally_recognized_as_safe_and_effective wikiPageWikiLinkText "Generally recognized as safe and effective".
- Generally_recognized_as_safe_and_effective wikiPageWikiLinkText "generally recognized as safe and effective".
- Generally_recognized_as_safe_and_effective wikiPageUsesTemplate Template:Distinguish.
- Generally_recognized_as_safe_and_effective wikiPageUsesTemplate Template:Pharmacology-stub.
- Generally_recognized_as_safe_and_effective wikiPageUsesTemplate Template:Reflist.
- Generally_recognized_as_safe_and_effective subject Category:Legal_terms.
- Generally_recognized_as_safe_and_effective hypernym Designation.
- Generally_recognized_as_safe_and_effective type Place.
- Generally_recognized_as_safe_and_effective type Concept.
- Generally_recognized_as_safe_and_effective type Term.
- Generally_recognized_as_safe_and_effective type Thing.
- Generally_recognized_as_safe_and_effective comment "Generally recognized as safe and effective (abbreviated as GRASE, GRAS/E, or GRAS/GRAE) is designation for certain old drugs that do not require prior approval from the U.S. Food and Drug Administration in order to enter the United States marketplace because they are generally recognized as safe and effective by medical professionals.".
- Generally_recognized_as_safe_and_effective label "Generally recognized as safe and effective".
- Generally_recognized_as_safe_and_effective differentFrom Generally_recognized_as_safe.
- Generally_recognized_as_safe_and_effective sameAs Q5532529.
- Generally_recognized_as_safe_and_effective sameAs m.02vvsgv.
- Generally_recognized_as_safe_and_effective sameAs Q5532529.
- Generally_recognized_as_safe_and_effective wasDerivedFrom Generally_recognized_as_safe_and_effective?oldid=614648442.
- Generally_recognized_as_safe_and_effective isPrimaryTopicOf Generally_recognized_as_safe_and_effective.