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
- 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
- Webinar on FDA’s Safety Monitoring of Approved Vaccines
- FDA Basic Video: Dianne Murphy Discusses Effective and Proper Uses of Medicines and Devices in Children (Video)
- FDA Basic Video: Norman Baylor Discusses Vaccines (Video)
- FDA Webinar on Safety of the Blood Supply
- FDA Webinar on Protecting Your Child's Health Through Safe and Effective Vaccines
- What are stem cells? How are they regulated?
- What is thimerosal? Is it safe when used in some vaccines?
- How can I get my name removed from a donor deferral list?
- What is a biological product?
- How does FDA regulate tissue products? What safeguards are in place for recipients?
- How do I know if I’m eligible to donate blood?
- 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?
How helpful was this information?