21 CFR Part 312 Flashcards
What does 21 CFR Part 312 cover?
Investigational New Drug Application
clinical investigation of a drug product that is lawfully marketed in the US is exempt from the requirements of part 312 if all of the following applies:
1) The investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication 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 investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant 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.
What products are exempt from requirements of 312?
1) blood grouping serum
2) reagent red blood cells
3) anti-human globulin.
In what setting is a drug exempt from requirements of 312?
drugs intended solely for tests in vitro or in laboratory research animals
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
Placebo
Is an Unlabeled indication of drug/device subject to provisions of 320.31? (Applicability of requirements regarding an “Investigational New Drug Application”)
No, does not apply to the use in the practice of medicine for an unlabeled indication of a new drug product
(320.31 applies to bioavailability studies)
Independent ethics committee (IEC)
a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection.
Investigational new drug
a new drug or biological drug that is used in a clinical investigation.
FDA shall provide a written determination within ____ days after receiving IND application
30
Grounds for clinical holds on Phase I studies:
unreasonable risk
unqualified investigators
IB is misleading, inaccurate or incomplete
or IND doesn’t contain sufficient information to assess risk to subjects
Grounds for clinical holds on Phase II or III studies:
deficient protocol to meet stated objectives
When an ongoing study is on a clinical hold can new subjects be enrolled and what happens to subjects currently enrolled and on IP?
no new subjects,
subjects on IP have to stop unless specifically permitted by the FDA
Who can appeal the FDA’s decision for a clinical hold?
Sponsor
How must the FDA notify the sponsor of a clinical hold on an IP?
Can be imposed by telephone, rapid communication or in writing
What is required to resume study after clinical hold on IP?
Cited issues must be resolved and the FDA must notify the sponsor to proceed
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 “_____”
Inactive status
INDs that are “Inactive” for ___+ years may be terminated
5
For an IND, how soon should the sponsor report serious unexpected life-threatening safety events to FDA?
7 calendar days.
For an IND, how soon should the sponsor report serious unexpected safety events to FDA when not life-threatening?
15 calendar days.
For an IND, what form is used for the sponsor reporting serious unexpected safety events?
Form FDA 3500A
What does SUSAR stand for?
Suspected unexpected serious adverse reaction
For an IND, when do investigators report serious events to sponsors?
As soon as possible (typically stated in protocol). (15 Days)
For an IND, when is the annual report is provided to the FDA by the sponsor?
60 calendar days from the anniversary of the IND becoming active.
True or False: Reactions which are serious but expected are subject to expedited reporting requirements
False. Reactions that are serious but unexpected are subject to expedited reporting.