FDA Forms

Question 1

FDA Form 482

Answer 1

FDA Form 482: Notice of Inspection
presented to the investigator that gives the FDA the authority to access, inspect and copy any required records related to the clinical investigation.

Question 2

FDA Form 483

Answer 2

FDA Form 483: Inspectional Observations - At the conclusion of an inspection, Form 483 is presented and discussed with the company’s senior management to notify the company’s management of objectionable conditions.

Question 3

FDA Form 1572

Answer 3

FDA Form 1572: Statement of Investigator - A form that must be filed by an investigator running a clinical trial to study a new drug or agent.

Question 4

FDA Form 3454

Answer 4

FDA Form 3454: CERTIFICATION: FINANCIAL INTERESTS AND
ARRANGEMENTS OF CLINICAL INVESTIGATORS Complete form 3454 if none of the investigators have any FDA required financial disclosures.

Question 5

FDA Form 3455

Answer 5

FDA Form 3455: DISCLOSURE: FINANCIAL INTERESTS AND
ARRANGEMENTS OF CLINICAL INVESTIGATORS if any clinical investigator has a financial disclosure that is significant.

Question 6

FDA Form 3500

Answer 6

FDA Form 3500: For Voluntary Reporting of Adverse Events
and Product Problems

Question 7

FDA Form 3500A

Answer 7

FDA Form 3500A - For Use by User-Facilities, Distributors,
and Manufacturers for Mandatory Reporting