[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: 21CFR601.28]

[Page 38]
 
                        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. 601.28  Annual reports of postmarketing pediatric studies.

    Sponsors of licensed biological products shall submit the following 
information each year within 60 days of the anniversary date of approval 
of each product under the license to the Director, Center for Biologics 
Evaluation and Research or the Director, Center for Drug Evaluation and 
Research (see mailing addresses in Sec. 600.2 of this chapter):
    (a) Summary. A brief summary stating whether labeling supplements 
for pediatric use have been submitted and whether new studies in the 
pediatric population to support appropriate labeling for the pediatric 
population have been initiated. Where possible, an estimate of patient 
exposure to the drug product, with special reference to the pediatric 
population (neonates, infants, children, and adolescents) shall be 
provided, including dosage form.
    (b) Clinical data. Analysis of available safety and efficacy data in 
the pediatric population and changes proposed in the labeling based on 
this information. An assessment of data needed to ensure appropriate 
labeling for the pediatric population shall be included.
    (c) Status reports. A statement on the current status of any 
postmarketing studies in the pediatric population performed by, or on 
behalf of, the applicant. The statement shall include whether 
postmarketing clinical studies in pediatric populations were required or 
agreed to, and, if so, the status of these studies shall be reported to 
FDA in annual progress reports of postmarketing studies under Sec. 
601.70 rather than under this section.

[65 FR 59718, Oct. 6, 2000, as amended at 65 FR 64618, Oct. 30, 2000; 70 
FR 14984, Mar. 24, 2005]