Regulations.gov document
Ref. 15 - Good Review Managment Principles and Practice for New Drug Applications and…
Supporting & Related Material · FDA-1995-D-0288 · posted Jul 7, 2021
Key facts
| Document ID | FDA-1995-D-0288-0054 |
|---|---|
| Title | Ref. 15 - Good Review Managment Principles and Practice for New Drug Applications and Biologics License Sept 2018 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-1995-D-0288 |
| Posted | Jul 7, 2021 |
At a glance
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