Understanding Substantial Evidence: A Key Legal Concept

Q: How does substantial evidence differ from other standards of proof?

It is less rigorous than the preponderance of evidence and more than a mere scintilla.

Q: Where can I find legal forms related to substantial evidence?

You can explore US Legal Forms for templates relevant to drug approval and other legal matters.

Definition & Meaning

Substantial evidence is a type of proof that a reasonable person would find adequate to support a conclusion. It is more than just a small amount of evidence but less than what is needed to meet the standard of a preponderance of the evidence. In the context of drug effectiveness, it refers to results from well-controlled investigations, such as clinical studies, conducted by qualified experts, which comply with regulations set by the Food and Drug Administration (FDA).

Table of content

Legal Use & context

This term is commonly used in various legal contexts, particularly in administrative law and regulatory frameworks. It plays a crucial role in cases involving the approval of drugs and medical treatments, where substantial evidence is required to demonstrate efficacy and safety. Users may encounter this term when dealing with health-related legal matters, including appeals related to FDA decisions. Legal forms related to these processes can often be found on platforms like US Legal Forms, which provide templates for self-management of such issues.

Key legal elements

Real-world examples

Here are a couple of examples of abatement:

One example of substantial evidence is a clinical trial demonstrating that a new medication effectively treats a specific condition. If the trial shows statistically significant results, it may provide substantial evidence for the drug's approval by the FDA. (hypothetical example)

Relevant laws & statutes

The primary legal reference for substantial evidence in the context of drug approval is found in the Federal Food, Drug, and Cosmetic Act, specifically 21 USCA § 355(e). This statute outlines the requirements for demonstrating the effectiveness of drugs.

Comparison with related terms

Term	Definition	Difference
Preponderance of Evidence	The greater weight of evidence required in civil cases.	Substantial evidence is less than this standard.
Clear and Convincing Evidence	A higher standard than preponderance, requiring a firm belief in the truth of the evidence.	Substantial evidence is not as rigorous as this standard.

Common misunderstandings

What to do if this term applies to you

If you believe substantial evidence is relevant to your situation, consider gathering documentation from qualified experts or conducting a controlled study if applicable. You can explore US Legal Forms for templates that may assist you in preparing necessary legal documents. If your case is complex, consulting a legal professional is advisable to ensure compliance with all regulations.

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Quick facts

Standard of proof: More than a scintilla, less than preponderance.
Commonly used in: Drug approval processes, administrative law.
Key requirement: Evidence from controlled studies by qualified professionals.

Key takeaways

Frequently asked questions

What is substantial evidence?

Substantial evidence refers to proof that a reasonable person would find adequate to support a conclusion, particularly in legal contexts.