What is FDA?

The Food and Drug Administration (FDA) is the United States Government body of Health and Human Services.

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 Classification of Medical Devices

FDA regulates a broad range of medical devices, including complicated, high-risk medical devices, like artificial hearts, and relatively simple, low-risk devices, like tongue depressors, as well as devices that fall somewhere in between, like sutures. FDA has authority to regulate medical devices before and after they reach the marketplace. Companies that design, manufacture, repackage, relabel, and/ or import medical devices into the United States are regulated by FDA's Centre for Devices and Radiological Health (CDRH). 

FDA Classification of Drugs

Over-the-counter and prescription drugs, including generic drugs, are regulated by FDA's Centre for Drug Evaluation and Research (CDER). This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs."

Drug companies seeking FDA approval to sell a new prescription drug in the United States must test it in various ways. First are laboratory and animal tests. Next are tests in humans to see if the drug is safe and effective when used to treat or diagnose a disease.

After testing the drug, the company then sends FDA an application called a New Drug Application (NDA). Some drugs are made out of biologic materials. Instead of an NDA, new biologic drugs are approved using a Biologics License Application (BLA). Whether an NDA or a BLA, the application includes:

• The drug's test results
• Manufacturing information to demonstrate the company can properly manufacture the drug
• The company's proposed label for the drug. The label provides necessary information about the drug, including uses for which it has been shown to be effective, possible risks, and how to use it.

If a review by FDA physicians and scientists shows the drug's benefits outweigh its known risks and the drug can be manufactured in a way that ensures a quality product, the drug is approved and can be marketed in the United States.

FDA Classification of Vaccines, Blood, and Biologics

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 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. Where can I find out more about the FDA? Visit http://www.fda.gov for more information.

How can PRISYMID help?

PRISYM Medica labelling software is purpose design labelling solution for Life Science organisations specifically developed to meet the FDA's current 21 CFR Part 11 compliance requirements. PRISYM Medica is supplied as a validated labelling 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.