[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: 21CFR601.94]

[Page 47]
 
                        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 H_Approval of Biological Products When Human Efficacy Studies 
                       Are Not Ethical or Feasible
 
Sec. 601.94  Promotional materials.

    For biological products being considered for approval under this 
subpart, unless otherwise informed by the agency, applicants must submit 
to the agency for consideration during the preapproval review period 
copies of all promotional materials, including promotional labeling as 
well as advertisements, intended for dissemination or publication within 
120 days following marketing approval. After 120 days following 
marketing approval, unless otherwise informed by the agency, the 
applicant must submit promotional materials at least 30 days prior to 
the intended time of initial dissemination of the labeling or initial 
publication of the advertisement.