21 CFR Part 312

Question 1

What does 21 CFR Part 312 cover?

Answer 1

Investigational New Drug Application

Question 2

clinical investigation of a drug product that is lawfully marketed in the US is exempt from the requirements of this part if all of the following applies:

Answer 2

1. The investigation is not intended to be reported to the FDA as a well-controlled study in suppport of a new indicatino for use nor intended to be used to support any other significant change in the labeling of the drug. 2) If the drug that is undergoing investiagtion is lawfully marketed as a prescription drug product, the investigation is not intended to support a significnat change in the advertising for the product. 3) The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks associated with the use of the drug product. 4) Investigation is conducted in compliance w/ the IRB and appropriately consents. 5) Investigation is conducted in compliance with the requirements.

Question 3

What products are exempt from requirements of 312?

Answer 3

1) blood grouping serum 2) reagent red blood cells, and 3) anti-human globulin.

Question 4

In what setting is a drug exempt from requirements of 312?

Answer 4

drugs intended solely for tests in vitro or in laboratory research animals.

Question 5

A clinical investigation involving use of THIS is exempt from the requirements of 312 if the investigation does not otherwise require submission of an IND

Answer 5

Placebo.

Question 6

Are bioavailability studies subject to provisions of 320.31?

Answer 6

YES

Question 7

Is an Unlabeled indication of drug/device subject to provisions of 320.31?

Answer 7

No, does not apply to the use in the practice of medicine for an unlabeled indication of a new drug product

Question 8

Independent ethics committee (IEC)

Answer 8

a review panel that is responsibile for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately consititued to prvode assurance of that protection.

Question 9

Investigational new drug

Answer 9

a new drug or biological drug that is used in a clinical investigation.

Question 10

FDA shall provide a written determination within ____ days after receiving IND application

Answer 10

30 days

Question 11

Grounds for clinical holds on Phase I studies:

Answer 11

1. unreasonable risk
2. unqualified investigators
3. IB is misleading, inaccurate or incomplete
4. or IND doesn’t contain sufficient information to assess risk to subjects

Question 12

Grounds for clinical holds on Phase II or III studies:

Answer 12

deficient protocol to meet stated objectives

Question 13

When an ongoing study is on a clinical hold can new subjects be enrolled and what happens to subjects currently enrolled and on IP?

Answer 13

no new subjects,

subjects on IP have to stop unless specifically permitted by the FDA

Question 14

Who can appeal the FDA’s decision for a clinical hold?

Answer 14

The sponsor

Question 15

How must the FDA notify the sponsor of a clinical hold on an IP?

Answer 15

Can be imposed by telephone, rapid communication or in writing

Question 16

What is required to resume study after clinical hold on IP?

Answer 16

Cited issues must be resolved and the FDA must notify the sponsor to proceed

Question 17

Under an IND, if no subjects are entered into a study for 2+ years or if all studies under an IND remain on clinical hold for 1 year+, the IND may be placed on “_____”

Answer 17

Inactive status

Question 18

INDs that are “Inactive” for ___+ years may be terminated

Answer 18

5+ years