Guidance document : data requirements for safety and effectiveness of subsequent entry inhaled corticosteroid products used for the treatment of asthma.: H13-9/29-2018E-PDF
"This guidance is intended to assist sponsors in the collection and analysis of comparative clinical data for Inhaled Corticosteroid (ICS) products used for the treatment of asthma that contain the same medicinal ingredient and have the same conditions of use as the Canadian Reference Product (CRP) in order to meet the safety and effectiveness requirements under C.08 of the Food and Drug Regulations [Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3)]. The data and standards outlined in this guidance are intended to be applied to a new ICS product being compared to a product for which clinical safety and effectiveness data exist. For clarity, these types of products will be referred to as “subsequent entry ICS products” in this document"--Introduction, page 5.
Permanent link to this Catalogue record:
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| Department/Agency |
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| Title | Guidance document : data requirements for safety and effectiveness of subsequent entry inhaled corticosteroid products used for the treatment of asthma. |
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| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Digital text |
| Electronic document | |
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| Publishing information |
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| Description | 1 online resource (14 pages) |
| ISBN | 9780660282299 |
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| Departmental catalogue number | Pub.: 180404 |
| Subject terms |
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