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Jul 10, 2012 ... is required to amend its 505(b)(2) application to include documentation of ..... carried out under an IND, was the applicant identified on the FDA ...
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An amendment form is required to make changes to a previously filed document.
The individual or entity who originally filed the document is required to file the amendment.
The individual or entity should complete the required sections of the amendment form with the updated information.
The purpose of an amendment is to update or correct information that was previously filed with the appropriate authority.
The updated or corrected information that needs to be reported on the amendment form.
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