FDA Forms

Question 1

What is Form FDA 482?

Answer 1

Notice of Inspection

Question 2

What is Form FDA 483?

Answer 2

Inspection Observations

Question 3

What is Form FDA 1571?

Answer 3

Investigational new Drug Application (IND)

Question 4

What is Form FDA 1572?

Answer 4

Statement of Investigator
Note: This only applies to trials of drugs or biologics conducted under an IND

Question 5

What is Form FDA 3454?

Answer 5

Certification of Financial Interest
Note: This form is completed when the Investigator has NO financial interests to disclose
Note: Applicable in all clinical trials that will be conducted in support of a marketing application
Note: Remember C (certification 3454) before D (disclosure 3455) in the alphabet

Question 6

What is Form FDA 3455?

Answer 6

Discolosure of Financial Interests
Note: Applicable in all clinical trials that will be conducted in support of a marketing application
Note: Remember C (certification 3454) before D (disclosure 3455) in the alphabet
Note: Investigator’s FDFs are stored for 2 years after application approval.

Question 7

What is Form FDA 3500?

Answer 7

Voluntary reporting of Adverse Events
Note: This form can be used by healthcare professionals and consumers.

Question 8

What is Form FDA 3500A?

Answer 8

Mandatory reporting of Events
Note: For use by IND reporters, manufacturers, distributers, and importers.