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• • • • • • • • •, including: • Mailing addresses • Instructions for forms • FDA's receipt of the IND Forms: • ): Investigational New Drug Application (IND) •: Statement of Investigator •: Certification of Compliance •: Certification: Financial Interests and Arrangements of Clinical Investigators •: Disclosure: Financial Interest and Arrangements of Clinical Investigators •: MedWatch Medical Product Reporting Program - Voluntary •: Medwatch Medical Products Reporting Program - Mandatory •: Individual Patient Expanded Access Applications • For electronic form submissions, see.

• I authorize the use of a copy (including electronic copy) of this form for the disclosure of the information described above in Section I. • I understand that there are some circumstances in which this information may be re-disclosed to other parties (See page 2 for details).

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