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  1. Center for Drug Evaluation and Research | CDER

Forms & Reports

FDA Forms [PDFs]

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

 

 MedWatch Forms: FDA Medical Product Reporting Program
 

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

MedWatch Home Page
 

 Other FDA Forms