[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.44]

[Page 39]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 601--LICENSING--Table of Contents
 
 Subpart E--Accelerated Approval of Biological Products for Serious or 
                       Life-Threatening Illnesses
 
Sec. 601.44  Postmarketing safety reporting.

    Biological products approved under this program are subject to the 
postmarketing recordkeeping and safety reporting applicable to all 
approved biological products.