Understanding Biological Product [Food and Drugs]: A Legal Perspective
Definition & Meaning
A biological product is any product derived from living organisms that is used for the prevention, treatment, or cure of diseases or injuries in humans. This includes various types of products such as:
- Viruses: These are products that contain the living agents of infectious diseases, including filterable viruses, bacteria, rickettsia, fungi, and protozoa.
- Therapeutic serums: These are obtained from blood by separating the liquid portion from the solid components.
- Toxins: These are poisonous substances that can cause harm in small doses and can stimulate the body to produce a neutralizing agent.
- Antitoxins: These are substances found in the body fluids of immunized animals that neutralize specific toxins.
- Analogous products: These are products similar to viruses or serums, derived from blood or other organic materials, intended for similar medical purposes.
Legal Use & context
Biological products are primarily regulated by the Food and Drug Administration (FDA) under the Public Health Service Act. They are used in various legal contexts, particularly in healthcare, pharmaceuticals, and biotechnology. Legal professionals may encounter biological products in cases involving:
- Regulatory compliance for manufacturers.
- Intellectual property rights concerning patents.
- Liability claims related to adverse effects from these products.
Users can manage related legal documents through platforms like US Legal Forms, which provide templates for compliance and liability waivers.
Real-world examples
Here are a couple of examples of abatement:
Here are a couple of examples of biological products:
- Vaccines: These are biological products that stimulate the immune system to protect against specific diseases, such as the influenza vaccine.
- Monoclonal antibodies: These are engineered proteins designed to target specific antigens in the treatment of diseases like cancer (hypothetical example).
Relevant laws & statutes
The regulation of biological products is primarily governed by:
- Public Health Service Act: This act provides the framework for the regulation of biological products.
- 21 CFR Part 600: This section of the Code of Federal Regulations outlines the general provisions for biological products.