Regulations.gov document
SOPP 8212: Breakthrough Therapy Products - Designation and Management RE Chemistry…
Supporting & Related Material · FDA-2022-N-2396 · posted Nov 1, 2022
Key facts
| Document ID | FDA-2022-N-2396-0003 |
|---|---|
| Title | SOPP 8212: Breakthrough Therapy Products - Designation and Management RE Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2022-N-2396 |
| Posted | Nov 1, 2022 |
At a glance
- 1–9 Public comments on this docket
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