CFR section
21 CFR 601.12(f)(1): Changes to an approved application
PART 601-LICENSING · Subpart C-Biologics Licensing
Key facts
| Citation | 21 CFR 601.12(f)(1) |
|---|---|
| Section | Changes to an approved application |
| Part | PART 601-LICENSING |
| Subpart | Subpart C-Biologics Licensing |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (1) Labeling changes requiring supplement submission-FDA approval must be obtained before distribution of the product with the labeling change. Except as described in paragraphs (f)(2) and (f)(3) of this section, an applicant shall submit a supplement describing a proposed change in the package insert, package label, container label, or, if applicable, a Medication Guide required under part 208 of this chapter, and include the information necessary to support the proposed change. An applicant… |
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