Matches in DBpedia 2015-10 for { <http://dbpedia.org/resource/New_drug_application_(FDA)> ?p ?o }
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- New_drug_application_(FDA) abstract "The Food and Drug Administration's new drug application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following: Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks? Is the drug’s proposed labeling (package insert) appropriate, and what should it contain? Are the methods used in manufacturing the drug (good manufacturing practice [GMP]) and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity?".
- New_drug_application_(FDA) thumbnail New_Drug_Application_(FDA_148)_(8210965141).jpg?width=300.
- New_drug_application_(FDA) wikiPageExternalLink DrugLag.html.
- New_drug_application_(FDA) wikiPageExternalLink book-excerpt-prescription-drug-product-submissions.aspx.
- New_drug_application_(FDA) wikiPageID "1340774".
- New_drug_application_(FDA) wikiPageLength "10624".
- New_drug_application_(FDA) wikiPageOutDegree "34".
- New_drug_application_(FDA) wikiPageRevisionID "682557924".
- New_drug_application_(FDA) wikiPageWikiLink Abbreviated_New_Drug_Application.
- New_drug_application_(FDA) wikiPageWikiLink Aspirin.
- New_drug_application_(FDA) wikiPageWikiLink Biologic_License_Application.
- New_drug_application_(FDA) wikiPageWikiLink Biologic_license_application.
- New_drug_application_(FDA) wikiPageWikiLink Biologic_medical_product.
- New_drug_application_(FDA) wikiPageWikiLink Biopharmaceutical.
- New_drug_application_(FDA) wikiPageWikiLink Blind_experiment.
- New_drug_application_(FDA) wikiPageWikiLink Calcitonin.
- New_drug_application_(FDA) wikiPageWikiLink Category:American_medical_research.
- New_drug_application_(FDA) wikiPageWikiLink Category:Drug_safety.
- New_drug_application_(FDA) wikiPageWikiLink Category:Food_and_Drug_Administration.
- New_drug_application_(FDA) wikiPageWikiLink Category:Pharmaceutical_industry.
- New_drug_application_(FDA) wikiPageWikiLink Clinical_trial.
- New_drug_application_(FDA) wikiPageWikiLink Clinical_trials.
- New_drug_application_(FDA) wikiPageWikiLink Concise_Encyclopedia_of_Economics.
- New_drug_application_(FDA) wikiPageWikiLink David_R._Henderson.
- New_drug_application_(FDA) wikiPageWikiLink Double-blind.
- New_drug_application_(FDA) wikiPageWikiLink Drug_development.
- New_drug_application_(FDA) wikiPageWikiLink ECTD.
- New_drug_application_(FDA) wikiPageWikiLink Electronic_common_technical_document.
- New_drug_application_(FDA) wikiPageWikiLink Food_and_Drug_Administration.
- New_drug_application_(FDA) wikiPageWikiLink Generic_drug.
- New_drug_application_(FDA) wikiPageWikiLink Glucagon.
- New_drug_application_(FDA) wikiPageWikiLink Good_manufacturing_practice.
- New_drug_application_(FDA) wikiPageWikiLink Grandfathered.
- New_drug_application_(FDA) wikiPageWikiLink Growth_hormone.
- New_drug_application_(FDA) wikiPageWikiLink Hyaluronidase.
- New_drug_application_(FDA) wikiPageWikiLink Insulin.
- New_drug_application_(FDA) wikiPageWikiLink Inverse_benefit_law.
- New_drug_application_(FDA) wikiPageWikiLink Investigational_New_Drug.
- New_drug_application_(FDA) wikiPageWikiLink Kefauver_Harris_Amendment.
- New_drug_application_(FDA) wikiPageWikiLink Library_of_Economics_and_Liberty.
- New_drug_application_(FDA) wikiPageWikiLink New_Animal_Drug_Application.
- New_drug_application_(FDA) wikiPageWikiLink Novartis.
- New_drug_application_(FDA) wikiPageWikiLink Package_insert.
- New_drug_application_(FDA) wikiPageWikiLink Placebo.
- New_drug_application_(FDA) wikiPageWikiLink Regulation_of_therapeutic_goods.
- New_drug_application_(FDA) wikiPageWikiLink The_Concise_Encyclopedia_of_Economics.
- New_drug_application_(FDA) wikiPageWikiLink File:New_Drug_Application_(FDA_148)_(8210965141).jpg.
- New_drug_application_(FDA) wikiPageWikiLinkText "New drug application (FDA)".
- New_drug_application_(FDA) hasPhotoCollection New_drug_application_(FDA).
- New_drug_application_(FDA) wikiPageUsesTemplate Template:Cite_encyclopedia.
- New_drug_application_(FDA) wikiPageUsesTemplate Template:OCLC.
- New_drug_application_(FDA) wikiPageUsesTemplate Template:Reflist.
- New_drug_application_(FDA) wikiPageUsesTemplate Template:Regulation_of_therapeutic_goods_in_the_United_States.
- New_drug_application_(FDA) wikiPageUsesTemplate Template:Use_mdy_dates.
- New_drug_application_(FDA) subject Category:American_medical_research.
- New_drug_application_(FDA) subject Category:Drug_safety.
- New_drug_application_(FDA) subject Category:Food_and_Drug_Administration.
- New_drug_application_(FDA) subject Category:Pharmaceutical_industry.
- New_drug_application_(FDA) hypernym Vehicle.
- New_drug_application_(FDA) type MeanOfTransportation.
- New_drug_application_(FDA) comment "The Food and Drug Administration's new drug application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.".
- New_drug_application_(FDA) label "New drug application (FDA)".
- New_drug_application_(FDA) sameAs New_Drug_Application.
- New_drug_application_(FDA) sameAs Q1368197.
- New_drug_application_(FDA) sameAs Q1368197.
- New_drug_application_(FDA) wasDerivedFrom New_drug_application_(FDA)?oldid=682557924.
- New_drug_application_(FDA) depiction New_Drug_Application_(FDA_148)_(8210965141).jpg.
- New_drug_application_(FDA) isPrimaryTopicOf New_drug_application_(FDA).