U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration is responsible for protecting the public health by assuring safety, efficacy, and security or human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. It also is responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable.
LOPA meets or exceeds all FDA requirements under the good tissue practice (GTP) rule. This rule sets the requirements for the recovery, processing, storage, labeling, packaging and distribution of human cells and tissues in a way that prevents the introduction, transmission, or spread of communicable diseases. It also requires processors to report adverse reactions, to have labeling that contains accurate and complete information, and to allow FDA inspections to ensure compliance with regulations.
For more information please visit the FDA website at www.fda.gov.
