Products such as human drugs, animal drugs, biological products, complex medical devices, and food and color additives are approved by the U.S. Food and Drug Administration using a variety of methods depending on the product's possible risks. The approval process sometimes involves assessing researc
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
A drug company hoping to sell a drug in the United States must provide the U.S. Food and Drug Administration with research-based evidence proving the drugs benefits are greater than the risks. The FDA conducts an unbiased evaluation of the research before approving the drug for sale, states the FDA
The U.S. Food and Drug Administration approves high-risk class III medical devices after the device owner submits a premarket approval application and FDA personnel review it, reports the FDA. The FDA clears class II lower-risk devices after manufacturers prove that they are substantially equal to s
Gene therapy is an experimental technique performed by replacing a mutated gene with a healthy copy of the gene as an alternative to surgery or medications. It is designed to make a beneficial protein or introduce new genes to mutated cells to compensate for a patient's abnormal genes, explains Gene
As of 2015, diet pills that the U.S. Food and Drug Administration has approved include Contrave, which combines bupropion and naltrexone; Qsymia, which combines phentermine and topiramate; and Belviq, which is lorcaserin, according to WebMD. Although the three weight-loss drugs function similarly, a
According to Genetics Home Reference, gene therapy requires the use of healthy genes to treat illnesses. Instead of a person undergoing surgery, genes are introduced to a patient's body to replace corrupted DNA. Another method is to inactivate negative genes instead of replacing them.
The Mayo Clinic website has a list of commonly used Food and Drug Administration-approved weight loss drugs, and others can be found by searching the FDA website. As of April 2015, the list of commonly used approved drugs includes Qsymia, Belviq and Orlistat.
Though still experimental, gene therapy fixes genetic defects and potentially reduces the need for drugs, radiation or surgical intervention. Replacing bad genes with good ones may eventually cure Parkinson’s, Alzheimer’s, cancer and many other diseases.
Every new drug follows a unique path from preclinical animal testing to final approval for sale in the United States, according to the U.S. Food and Drug Administration. Despite the variability in the process, approval generally follows a seven-stage path to ensure safety and effectiveness.