21 CFR 601.50 - Confidentiality of data and information in an investigational new drug notice for a biological product.

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§ 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 § 601.51.
(c) Notwithstanding the provisions of § 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]

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 601 after this date.

  • 2015-02-18; vol. 80 # 32 - Wednesday, February 18, 2015
    1. 80 FR 8577 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of public meeting; request for comments; reopening of the comment period.
      Meeting. The public meeting will be held on March 27, 2015, from 8 a.m. to 5 p.m. Registration to attend the meeting must be received by March 20, 2015. See the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. Comments. The comment period for the proposed rule publilshed November 13, 2013 (78 FR 67985), is reopened. Submit either electronic or written comments regarding proposed alternatives to the proposed rule by April 27, 2015.
      21 CFR Parts 314 and 601