00000nam 2200000zi 4500 9.867966 CaOODSP 20241129150203 m o d f cr cn||||||||| 190204t20172017onc o f000 0 eng d CaOODSP eng rda CaOODSP n-cn--- H164-266/2018E-PDF Guidance document : quality (chemistry and manufacturing) guidance : new drug submissions (NDSs) and abbreviated new drug submissions (ANDSs). Quality (chemistry and manufacturing) guidance : new drug submissions (NDSs) and abbreviated new drug submissions (ANDSs) [Ottawa] : Health Canada = Santé Canada, [2017] ©2017. 1 online resource (vi, 85 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Ligne directrice : qualité (chimie et fabrication) : présentations de drogue nouvelle (PDN) et présentations abrégées de drogue nouvelle (PADN). Cover title. "Health Products and Food Branch." Includes addendum (questions and answers). Issued also in HTML format. gccst Drugs gccst Health policy Canada. Health Canada. Canada. Health Products and Food Branch. Ligne directrice : (CaOODSP)9.867968 Quality (chemistry and manufacturing) guidance : (CaOODSP)9.945784 PDF 336 KB https://publications.gc.ca/collections/collection_2019/sc-hc/H164-266-2018-eng.pdf (guidance document) PDF 58 KB https://publications.gc.ca/collections/collection_2019/sc-hc/H164-266-2018-1-eng.pdf (addendum) HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/chemical-entity-products-quality/guidance-document-quality-chemistry-manufacturing-guidance-new-drug-submissions-ndss-abbreviated-new-drug-submissions.html (guidance document)