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  1. Office of Medical Products and Tobacco

Forms & Reports

Forms & Reports

FDA Forms [PDFs]

Form FDA 463aAffidavit
Form FDA 1571Investigational New Drug Application
Form FDA 1572Statement of Investigator
Form FDA 3454Certification: Financial Interests and Arrangements of Clinical Investigators
Form FDA 3455Disclosure: Financial Interests and Arrangements of Clinical Investigators

 

 MedWatch Forms: FDA Medical Product Reporting Program
 

Form 3500for Voluntary reporting of adverse events (side effects) and product problems
Form 3500afor use by user-facilities, distributors and manufacturers for Mandatory reporting

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