Guidance on post-notice of compliance changes : overall quality document for biologic and Schedule C drugs for human use.: H164-424/2026E-PDF
"This guidance document applies to sponsors intending to make changes to drugs that have received a NOC pursuant to Section C.08.004 of the Food and Drug Regulations, that are biologics and Schedule C drugs (radiopharmaceuticals and cold kits) for human use including those submissions for which a NOC has been recommended but the issuance of the NOC has been placed on hold"--page 1.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.961955&sl=0
| Department/Agency |
|
|---|---|
| Title | Guidance on post-notice of compliance changes : overall quality document for biologic and Schedule C drugs for human use. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Digital text |
| Electronic document | |
| Note(s) |
|
| Publishing information |
|
| Description | 1 online resource (ii, 26 pages) |
| ISBN | 9780660995779 |
| Catalogue number |
|
| Departmental catalogue number | 260041 |
| Subject terms |
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