Regulations.gov document
Q11 Development and Manufacture of Drug Substances—Questions and Answers (Chemical…
Notice · FDA-2011-D-0436 · posted Feb 26, 2018
Key facts
| Document ID | FDA-2011-D-0436-0028 |
|---|---|
| Title | Q11 Development and Manufacture of Drug Substances—Questions and Answers (Chemical Entities and Biotechnological/Biological Entities); International Council for Harmonisation; Guidance for Industry; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2011-D-0436 |
| Posted | Feb 26, 2018 |
| Federal Register citation | 83 FR 8279 |
| FR document number | 2018-03809 |
| Comment period opens | Feb 26, 2018 |
| Effective date | Feb 26, 2018 |
At a glance
- 1–9 Pages
- 10–99 Public comments on this docket
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