supplement to a new drug submission
- Guideline or reference source
- HC Creation of the canadian module 1 backbone
- Definition
- Manufacturers must submit information in a Supplement to a New Drug Submission (SNDS) when they plan to make significant manufacturing changes or modify recommendations for use (labelling) for previously approved drugs, as per section C.08.003 and C.08.003.1 of the Food and Drug Regulations.
- Abbreviation for
- SNDS
- Related Term
- new drug submission
- supplement type
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