Glossary of Clinical Terms

The Food and Drug Administration (FDA) of the United States is a federal regulatory agency responsible for protecting and promoting public health through the regulation and supervision of food safety, drugs, medical devices, vaccines, biologics, and other products. The FDA is responsible for ensuring that drugs, medical devices, and other products intended for human use are safe, effective, and of high quality.

The FDA also works to ensure that food and cosmetics are safe and properly labeled. The agency was established in 1906 and operates under the Department of Health and Human Services. The FDA’s regulatory authority is based on the Federal Food, Drug, and Cosmetic Act, as well as several other laws and regulations. In addition to its regulatory functions, the FDA also provides information to the public about health and safety issues, conducts research, and collaborates with other agencies and organizations to promote public health.

Roles of the FDA:

The FDA has jurisdiction over many items that are regulated by law, including:

1. Biologics: (CBER- Centre for Biologic Evaluation and Research)

◾ Blood/Blood products
◾ Cellular and gene therapy
◾ Tissue/Tissue Products
◾ Vaccines

2. Drugs: (CDER- Centre for Drug Evaluation and Research)

◾ OTC and prescription drugs
◾ Biological therapeutics and generic drugs

3. Medical Devices (CDRH Centre for Devices and Radiological Health)

◾ Class 1: e.g., toothbrushes, tongue depressors, etc.
◾ Class 2: Premarket notification is required, not approval.
◾ Class 3: Premarket approval is required.

4. Veterinary Products (CVM, Centre for Veterinary Medicines)
◾ Drugs for animal use
◾ Animal foods
◾ Veterinary devices

5. Foods
6. Cosmetics
7. Tobacco products

Spring Bio Solution in the US is registered with the USFDA for its licensed facility.