About FDA
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What is a biological product?
Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include
- vaccines
- blood and blood products for transfusion and/or manufacturing into other products
- allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
- human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
- gene therapies
- cellular therapies
- tests to screen potential blood donors for infectious agents such as HIV
Show all related FDA Basics Questions
- FDA Basic Video: Norman Baylor Discusses Vaccines (Video)
- Webinar on FDA’s Safety Monitoring of Approved Vaccines
- FDA Webinar on Safety of the Blood Supply
- FDA Webinar on Protecting Your Child's Health Through Safe and Effective Vaccines
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- How does FDA regulate tissue products? What safeguards are in place for recipients?
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- How do I report an adverse event related to a vaccine?
- What is the Vaccine Adverse Event Reporting System (VAERS)?
- How does FDA assess the safety of vaccines?
- What is the approval process for a biological product?
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