FDA Approval Process
FDA's approval process for the products it regulates, are as varied as the products themselves. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to consumers. FDA aims to provide 'safe and effective' products to the consumers. From product testing to label scrutiny, FDA tests almost every aspect of food and drugs in order to ensure that they are 'safe and effective' to use.
It might have never crossed your mind that most of the products that you use throughout the day are regulated by FDA. The Label on the juice can you lift for the morning breakfast, the cosmetics you apply to your latest hair color or the pain relief medicine that you take are all, FDA approved. With FDA approved goods, you can be sure that you are not being fooled by the deceptive ingredients on the label of the product. FDA approval process makes sure that the tested materials are used in the production of the goods, be it drugs, cosmetics or food items.
At FDA, the motto is to ensure consumer's safety and satisfaction with the daily drugs and food that they consume. FDA however follows a strict mission, tracking the following four roles according to the Food and Drug Modernization Act:
- To promote health by reviewing research and approving new products.
- To ensure that foods and drugs are safe and properly labeled.
- To work with other nations to 'reduce the burden of regulation'
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- To cooperate with experts and consumers to effectively carry out these obligations.
Companies need to have food licenses before they sell the food products in the US markets. Some products such as new drugs and complex medical devices must be proven safe and effective before they can be FDA approved. Also, FDA approves new food additives (a food license per se) before they can be used in food production. Other products such as X-ray machines and microwave ovens must measure up to performance standards. And some products such as cosmetics and dietary supplements can generally be marketed without prior FDA approval.
At the heart of FDA approval of medical products is a judgment about whether a new product's benefit to users outweigh its risk. No regulated product is totally risk-free, so these judgments are important.
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