Differences between Device and Drug Regulation
Here are a few definitions: Clinical
investigation is nothing but an investigation involving a test article and one
or more than one human subjects.
A Drug is known as a substance
recognized by an official pharmacopoeia or formulary. Drug is a substance used
in diagnosis, treatments or prevention of a disease.
An investigational Drug means a
new drug that is used in a clinical investigation. The term also includes a
biological product that is used in vitro for diagnostic purposes.
Research Involving Drugs Exempt
from IND Requirements: Research Involving Drugs Exempt from IND Requirements
means a clinical research of a marketed drug (i.e , an FDA-approved drug) is
exempt from the IND requirements if every criteria for exemption are truly met:
The drug product is marketed in the United States lawfully; the investigation
is not planned to be reported to the FDA as a well-controlled study supporting
a new indication and there is no intent to use it to support any other major
change in the labeling of the drug. As per the Investigational Device Exemption
regulations there are three types of device investigations: Exempt Device
Studies, Non-significant Risk (NSR) Device Studies and Significant Risk (SR)
Device Studies.
Clinical Investigation: The term
Clinical Investigation refers to any research involving one or more than one subjects
to determine the safety and effectiveness of a device.
http://www.onlinecompliancepanel.com/webinar/DeviceAndDrugResearch-501007/OCT-2015-SMThis webinar will discuss the
differences between device and drug clinical research and the current
regulations governing the use of drugs and devices in a clinical study.
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