Glossary

Manufacturing Supplement

[FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the facility(ies) involved in the manufacturing of the product (may include labeling changes as well). Also called a CMC Supplement.

Source: SOPP 8401.2: Administrative Processing of BLA and NDA Supplements

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Glossary

The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.

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