§ 431.70 - Confidentiality of data and information in an investigational new drug notice for an antibiotic drug.

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(a) The existence of an IND notice for an antibiotic drug 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 an antibiotic drug shall be handled in accordance with the provisions established in § 314.430 of this chapter.

(c) Notwithstanding the provisions of § 314.430 of this chapter, the Food and Drug Administration shall disclose upon request to an individual on whom an investigational antibiotic has been used a copy of any adverse reaction report relating to such use.

                    
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