FDA的批准后变更的相关指南

皮妈

1.         21 CFR314.70, 21 CFR314.81, or 21CFR 514.8, as appropriate.21 CFR 314.70, 21 CFR 314.81, 或21 CFR 514.8

2.  The guidancefor industry Changes to an Approved NDA or ANDA or Chemistry, Manufacturing, andControls Changes to an Approved NADA or ANADA, as 行业指南“已批准NDA或ANDA变更或已批准ANDA或ANADA的CMC变更”

3. The guidance for industry Changes toan Approved NDA or ANDA Questions and 行业指南“已批准NDA或ANDA变更问答”

4. The guidance for industry CMC Postapproval ManufacturingChanges to Be Documented in Annual Reports.行业指南“在年报中记录的CMC批准后生产变更

5. Drug Master Files Guidance for Industry （draft guidance）药物主文件行业指南 （指导草案）2019年10月 第一版

6. Postapproval Changes to Drug Substances Guidancefor Industry （draft guidance）原料药批准后变更（草案）

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