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Understanding Covered Clinical Study [Food and Drugs]: A Legal Perspective
Definition & Meaning
A covered clinical study refers to any research involving a drug or medical device tested on humans that is submitted as part of a marketing application or reclassification petition. This term is crucial as it identifies studies that the applicant or the Food and Drug Administration (FDA) uses to demonstrate a product's effectiveness or safety. Generally, covered clinical studies do not include phase I tolerance studies, pharmacokinetic studies, or large open safety studies conducted at multiple sites. Applicants may consult with the FDA to clarify which studies qualify as covered clinical studies for financial disclosure purposes.
Table of content
Legal Use & context
Covered clinical studies are significant in the fields of pharmaceutical and medical device regulation. They are primarily used in the context of FDA submissions for marketing approval. Understanding which studies are classified as covered is essential for compliance with financial disclosure regulations. This involves legal practices associated with healthcare law, regulatory compliance, and potentially litigation related to drug or device safety and efficacy.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company conducts a randomized controlled trial on a new medication to treat diabetes. This study is submitted to the FDA as part of its marketing application, making it a covered clinical study.
Example 2: A medical device manufacturer performs a clinical trial to evaluate the safety and effectiveness of a new heart valve. This study is included in their reclassification petition to the FDA, qualifying it as a covered clinical study.
Relevant laws & statutes
Pursuant to 21 CFR 54.2, covered clinical studies are defined and regulated under the Food, Drug, and Cosmetic Act. This regulation outlines the requirements for financial disclosures by clinical investigators involved in such studies.
Comparison with related terms
Term
Definition
Difference
Clinical Study
A broader category of research involving human subjects.
Covered clinical studies are a specific subset required for FDA submissions.
Phase I Study
Initial studies to assess safety and dosage.
Phase I studies are generally excluded from the definition of covered clinical studies.
Common misunderstandings
What to do if this term applies to you
If you are involved in a clinical study that may be classified as a covered clinical study, it is crucial to understand the implications for financial disclosures. You may want to consult with a legal professional specializing in FDA regulations to ensure compliance. Additionally, consider using US Legal Forms' templates for guidance on financial disclosure requirements.
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