21 CFR part 312 Flashcards
what does 21 CFR part 312 cover?
investigational new drug application
a clinical investigation of a drug product that’s lawfully marketed in the US is exempt from part 312 if (5):
1) investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor be used to support any other significant change in the labeling of a drug
2) if the drug is lawfully marketed as prescription, the investigation is not intended to support a significant change in the advertising for the product
3) doesn’t involve a route of admin or dosage level or use in a patient population or other factor that significantly increased risks
4) conducted in compliance w/ IRB and appropriately consents
5) conducted in compliance w/ requirements
products exempt from part 312 requirements:
blood grouping serum, reagant red blood cells, anti-human globulin
when is a drug exempt from 312 requirements?
drugs intended solely for tests in vitro or in lab research animals
an investigation involving use of ______ is exempt from 312 if the study does not otherwise require submission of an IND
placebo
true/false: bioavailability studies are subject to provisions of 320.31.
true
true/false: an unlabeled indication is subject to provisions of 320.31.
false. This does not apply to the use in the practice of medicine for an unlabeled indication of a new drug.
What’s an IEC?
review panel responsible for ensuring protection of rights, safety, and well-being of subjects
what’s an investigational new drug?
new drug or biological drug that is used in an investigation
how long does the FDA have to provide written determination after receiving an IND application?
30 days
4 grounds for clinical holds on phase I studies:
1) unreasonable risk
2) unqualified investigators
3) IB is misleading, inaccurate or incomplete
4) IND doesn’t contain sufficient info to assess risk
grounds for clinical holds on phase II or III studies:
deficient protocol to meet stated objectives
can new subjects be enrolled while a study is on a clinical hold?
no
what needs to be done with subjects currently enrolled and on IP for studies placed on hold?
must stop taking IP unless permitted by the FDA
who can appeal the FDA’s decision for a clinical hold?
sponsor
