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| 03079cam 2200409zi 4500 |
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001 | 9.907191 |
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003 | CaOODSP |
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005 | 20221107181325 |
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006 | m o d f |
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007 | cr mn||||||||| |
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008 | 220121t20092009onc o f000 0 eng d |
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040 | |aCaOODSP|beng|erda|cCaOODSP |
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043 | |an-cn--- |
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086 | 1 |aH169-4/2009E-PDF |
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245 | 00|aGuidance for industry : |bpriority review of drug submissions / |cHealth Products and Food Branch. |
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246 | 17|aPriority review of drug submissions |
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264 | 1|aOttawa, Ontario : |bHealth Canada = Santé Canada, |c2009. |
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264 | 4|c©2009 |
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300 | |a1 online resource (iii, 19 pages) |
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336 | |atext|btxt|2rdacontent |
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337 | |acomputer|bc|2rdamedia |
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338 | |aonline resource|bcr|2rdacarrier |
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500 | |a"Date Adopted: 2002/09/16." |
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500 | |a"Revised Date: 2005/11/30." |
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500 | |a"Effective Date: 2006/03/01." |
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500 | |a"Administrative Changes Date: 2008/12/18." |
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500 | |a"Notice: February 6, 2009." |
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500 | |a"File number: 09-101263-867." |
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500 | |aIssued also in HTML format. |
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500 | |aIssued also in French under title: Ligne directrice à l'intention de l'industrie : évaluation prioritaire des présentations de drogues. |
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520 | |a"This guidance is intended to provide assistance to sponsors in the interpretation of the Priority Review policy and in preparing and submitting a request for Priority Review status. It should be read in conjunction with the Priority Review of Drug Submissions Policy. All therapeutic products sold in Canada must meet safety and effectiveness requirements outlined in Part C of the Food and Drug Regulations. Special consideration relating to drug submissions qualifying under the Notice of Compliance with Conditions (NOC/c) policy, or those sold under C.08.010 and C.08.011 of the Food and Drug Regulations for Special Access purposes, may be warranted. For additional information on the NOC/c policy, refer to “Guidance for Industry; Notice of Compliance with Conditions (NOC/c)”. Information on Health Canada’s Special Access Program is available on the Health Canada Web site. This guidance aims to articulate Health Canada’s expectations and generate a level of consistency regarding the interpretation of the Priority Review of Drug Submissions policy and the filing of a Priority Review request. Additional clarification of the process by which the Priority Review request is assessed is provided"--Purpose, page 1. |
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650 | 0|aDrug approval|zCanada. |
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710 | 1 |aCanada. |bHealth Products and Food Branch, |eissuing body. |
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775 | 08|tLigne directrice à l'intention de l'industrie : |w(CaOODSP)9.907195 |
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795 | |tGuidance for industry - priority review of drug submissions |b2007|w(CaOODSP)9.688058 |
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856 | 40|qPDF|s345 KB|uhttps://publications.gc.ca/collections/collection_2022/sc-hc/H169-4-2009-eng.pdf |
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856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/priority-review/drug-submissions.html |
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