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What is the FDA?

WHAT IS IT?
The Food and Drug Administration (FDA) governs health and human services in the United States. It protects public health by enforcing safety and security regulations for drugs, vaccines, and other biological products and medical equipment.

WHY IS IT IMPORTANT?
The FDA is responsible for protecting public health by:

- Assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the US nation’s food supply, cosmetics, dietary supplements, and products that give off radiation
- Regulating tobacco products
- Advancing the public health by helping to speed product innovations
- Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health

FDA approved Classification of Medical Device
Vaccines, blood, and biologics are regulated by FDA’s Centre for Biologics Evaluation and Research (CBER). CBER protects and advances the public health by ensuring that these products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of these products.

Vaccines undergo rigorous and extensive testing to determine their safety and effectiveness. Highly trained scientists and medical personnel at FDA carefully review all of the information in a marketing application before a vaccine can be approved for use by the public. Following approval, FDA also carefully monitors the quality of vaccines.

FDA approved Classification of Animal & Veterinary
The manufacture and distribution of food additives and drugs that will be given to animals are regulated by the Center for Veterinary Medicine (CVM). These include animals used for human food, as well as food additives and drugs for pet (or companion) animals.

WHO IS IT RELEVANT TO?
The FDA is relevant to any organisation working in or supplying products to the US for health and human services. Visit http://www.fda.gov for more information.

HOW CAN PRISYM ID HELP?
PRISYM Medica labeling software is purpose design labelling solution for Life Science organizations specifically developed to meet the FDA’s current 21 CFR Part 11 compliance requirements. PRISYM Medica is supplied as a validated labeling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.

Available both as a thin or thick client, PRISYM Medica allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.