[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.14]

[Page 28]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 601_LICENSING--Table of Contents
 
                      Subpart C_Biologics Licensing
 
Sec. 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 Sec. 
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 Sec. Sec. 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 Sec. 11.10(a), (c) through (h), and (k), 
and the corresponding requirements of Sec. 11.30.

[68 FR 69020, Dec. 11, 2003]