CFR section
21 CFR 601.12(d): Changes to an approved application
PART 601-LICENSING · Subpart C-Biologics Licensing
Key facts
| Citation | 21 CFR 601.12(d) |
|---|---|
| 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) | (d) Changes to be described in an annual report (minor changes). (1) Changes in the product, production process, quality controls, equipment, facilities, or responsible personnel that have a minimal 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 shall be documented by the applicant in an annual report submitted each year within 60 days of the anniversary date of approval of… |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.