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e-CFR data is current as of September 17, 2020

Title 21Chapter ISubchapter FPart 601Subpart C → §601.14


Title 21: Food and Drugs
PART 601—LICENSING
Subpart C—Biologics Licensing


§601.14   Regulatory submissions in electronic format.

(a) General. Electronic format submissions must be in a form that FDA can process, review, and archive. FDA will periodically issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files.)

(b) Labeling. The content of labeling required under §201.100(d)(3) of this chapter (commonly referred to as the package insert or professional labeling), including all text, tables, and figures, must be submitted to the agency in electronic format as described in paragraph (a) of this section. This requirement is in addition to the provisions of §§601.2(a) and 601.12(f) that require applicants to submit specimens of the labels, enclosures, and containers, or to submit other final printed labeling. Submissions under this paragraph must be made in accordance with part 11 of this chapter except for the requirements of §11.10(a), (c) through (h), and (k), and the corresponding requirements of §11.30.

[68 FR 69020, Dec. 11, 2003]

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