[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: 21CFR601.50]

[Page 39]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 601--LICENSING--Table of Contents
 
                Subpart F--Confidentiality of Information
 
Sec. 601.50  Confidentiality of data and information in an investigational new drug notice for a biological product.


    (a) The existence of an IND notice for a biological product will not 
be disclosed by the Food and Drug Administration unless it has 
previously been publicly disclosed or acknowledged.
    (b) The availability for public disclosure of all data and 
information in an IND file for a biological product shall be handled in 
accordance with the provisions established in Sec. 601.51.
    (c) Notwithstanding the provisions of Sec. 601.51, the Food and Drug 
Administration shall disclose upon request to an individual on whom an 
investigational biological product has been used a copy of any adverse 
reaction report relating to such use.

[39 FR 44656, Dec. 24, 1974]

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