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Transfer of Sponsor ObligationsProtocol Title:Regulatory Sponsor:[Investigator Name and Institution] or [Company Name] Collaborators:[Investigator Name and Institution] or [Company Name] IND/IDE #:Effective
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How to fill out wwwfdagovdrugsinvestigational-new-drug-indinformation for sponsor-investigators submitting

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Go to the website www.fda.gov/drugs/investigational-new-drug-ind-information
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Click on the 'Submit' button to start the application process
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Fill out the required fields in the online form, providing accurate and complete information
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Upload any supporting documents, such as study protocols, investigator brochures, and safety data
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Who needs wwwfdagovdrugsinvestigational-new-drug-indinformation for sponsor-investigators submitting?

01
Sponsor-investigators who are submitting information related to investigational new drugs need to access the website www.fda.gov/drugs/investigational-new-drug-ind-information.

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wwwfdagovdrugsinvestigational-new-drug-indinformation is the information required by the FDA for sponsor-investigators submitting investigational new drug applications.
Sponsor-investigators are required to file wwwfdagovdrugsinvestigational-new-drug-indinformation when submitting investigational new drug applications.
wwwfdagovdrugsinvestigational-new-drug-indinformation must be filled out accurately and completely following the FDA guidelines.
The purpose of wwwfdagovdrugsinvestigational-new-drug-indinformation is to provide necessary information about the investigational new drug to the FDA.
Information such as drug composition, intended use, manufacturing process, and safety data must be reported on wwwfdagovdrugsinvestigational-new-drug-indinformation.
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