FDA Forms

Question 1

Form FDA 1571

Answer 1

Investigational New Drug Application

Question 2

Form FDA 1572

Answer 2

Statement of Investigator

Question 3

Form FDA 3454

Answer 3

Certification: Financial Interests and Arrangements of Clinical Investigators

Question 4

Form FDA 3455

Answer 4

Disclosure: Financial Interests and Arrangements of Clinical Investigators

Question 5

Form 3500 A

Answer 5

For use by user-facilities, distributors and manufacturers for Mandatory Reporting

Question 6

Form 3500

Answer 6

Voluntary submission by a health care professional with concerns about FDA-regulated product

Question 7

Form 3500 B

Answer 7

Voluntary reporting by consumers

Question 8

Form 482

Answer 8

Inspection Notice

Question 9

Form 483

Answer 9

FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.