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How are Pharmaceutical Drugs Approved?

Sometimes members of the public may not realize the process pharmaceutical drugs go through to receive approval and to reach them. The U.S. Food and Drug Administration works to ensure that the American pharmaceutical system remains the safest and most advanced in the world. The FDA's Center for Drug Evaluation and Research is responsible for evaluating drugs before they can be sold to the public.

The responsibilities of the CDER include ensuring that brand-name and generic drugs work as they are supposed to and that the health benefits of the drugs outweigh the known risks. Drug companies are required to test their drugs. They must send the results of their testing to the CDER so that the CDER can confirm the drugs are both safe and effective. An independent review of the data is conducted by the CDER to determine if the benefits of the drug outweigh the known risks. The CDER also reviews labeling for the drug proposed by the pharmaceutical company.

When a pharmaceutical company is testing a drug, it is first tested on animals to determine how the drug works, if it is safe, and if it is likely to work in humans. Following animal testing, tests on humans are conducted to determine the drug's efficacy and if it is safe for humans. Once the CDER is satisfied that a drug's health benefits outweigh the known risks of the drug, the drug will be approved for sale. While it is the responsibility of the pharmaceutical company to test the drug and provide evidence it is safe and effective, the CDER is responsible for approving the drug based on the information provided.

The drug approval process seeks to ensure that prescription drugs are safe and effective for consumers. The development process can be costly, time-consuming, and complex for pharmaceutical companies. At the same time, when a consumer has been harmed by a dangerous drug, it is important that the consumer is properly protected. Because of this, legal options are available to ensure that consumers do not unnecessarily suffer damages related to the use of a defective or dangerous drug.

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