CFR section
21 CFR 601.12(b): Changes to an approved application
PART 601-LICENSING · Subpart C-Biologics Licensing
Key facts
| Citation | 21 CFR 601.12(b) |
|---|---|
| Section | Changes to an approved application |
| Part | PART 601-LICENSING |
| Subpart | Subpart C-Biologics Licensing |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs |
| Regulation text (excerpt) | (b) Changes requiring supplement submission and approval prior to distribution of the product made using the change (major changes). (1) A supplement shall be submitted for any change in the product, production process, quality controls, equipment, facilities, or responsible personnel that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. (2) These changes… |
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