How Do You Get Approval From the FDA for a New Product?


Quick Answer

Companies that manufacture products that require Food and Drug Administration approval must prove that the products are safe and effective, or in the case of medical products, that the benefits outweigh the risks, reports the U.S. Food and Drug Administration. The FDA does not test the products but rather reviews research that companies conduct and submit. The process of testing and approving new drugs may take up to 12 years, points out Drugs.com.

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Full Answer

Products that must obtain preapproval before companies can market them include drugs, complex medical devices, and biologics such as vaccines and blood products, explains the FDA. The FDA also preapproves food additives, color additives, and drugs and food supplements for animals. Medical devices that are substantially equivalent to those already on the market and combined drugs that pharmacists or companies mix from already-approved medicines do not require FDA approval.

A drug typically goes through years of laboratory testing before a company applies for FDA permission to test it on humans, according to Drugs.com. The drug then goes through three phases of clinical trials with human subjects, each time with a larger pool of patient volunteers. When the testing is finished, the company submits a comprehensive application to the FDA, which may take years to review it. Even after final approval, the FDA continues to monitor data on adverse reactions to the drug. The FDA sometimes streamlines its review time of needed innovative drugs to six months or less, points out the FDA.

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