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Understanding Control Article [Food and Drugs]: A Legal Perspective
Definition & Meaning
A control article refers to any substance administered to a test system during a nonclinical laboratory study. This includes food additives, color additives, drugs, biological products, electronic products, and medical devices intended for human use. The purpose of using a control article is to provide a basis for comparison with the test article, which is the primary subject of the study. Essentially, it helps researchers understand the effects of the test article by comparing it to a known standard or control.
Table of content
Legal Use & context
The term "control article" is primarily used in the context of regulatory compliance within the food and drug industry. It is relevant in areas such as:
Pharmaceutical research
Food safety studies
Medical device testing
Legal practitioners may encounter this term when dealing with compliance issues related to laboratory studies. Users can manage related forms and procedures using templates available through US Legal Forms, which are drafted by licensed attorneys.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: In a study testing a new drug for diabetes, the control article might be a standard diabetes medication. Researchers would compare the effects of the new drug against this established treatment.
Example 2: In a food safety study, a control article could be a previously approved food additive, which is used to compare the effects of a new additive being tested. (hypothetical example)
Relevant laws & statutes
Control articles are governed under the Code of Federal Regulations, specifically Title 21, which pertains to food and drugs. Key regulations include:
21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
Comparison with related terms
Term
Definition
Difference
Test Article
The primary subject being tested in a study.
The control article is used for comparison, while the test article is the focus of the study.
Placebo
A substance with no therapeutic effect used as a control.
A placebo is a specific type of control article, often used in clinical trials.
Common misunderstandings
What to do if this term applies to you
If you are involved in a nonclinical laboratory study and need to manage control articles, consider the following steps:
Identify the control articles relevant to your study.
Ensure compliance with applicable regulations, such as 21 CFR Part 58.
Utilize US Legal Forms for templates related to laboratory studies to streamline your documentation.
If the situation is complex, consult a legal professional for tailored advice.
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