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Guidance for Industry on Changes to an Approved New Drug Application or Abbreviated New Drug Application; Availability; Correction

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 8, 2004 (69 FR 18768). The document announced the availability of a revised guidance for industry entitled “Changes to an Approved NDA or ANDA.” The document was published with inadvertent errors. This document corrects those errors.

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FOR FURTHER INFORMATION CONTACT:

Joyce A. Strong, Office of Policy and Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.

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SUPPLEMENTARY INFORMATION:

In FR Doc. 04-7533, appearing on page 18768 in the Federal Register of Thursday, April 8, 2004, the following corrections are made:

1. On page 18768, in the first column, under the FOR FURTHER INFORMATION CONTACT section, the contact information is corrected to read “David J. Cummings, Center for Drug Evaluation and Research (HFD-357), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5187.”

2. On page 18768, in the third column, the second full paragraph is removed.

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Dated: April 19, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 04-9324 Filed 4-23-04; 8:45 am]

BILLING CODE 4160-01-S