Asked by: Mercenario Mohaiemen
asked in category: General Last Updated: 2nd April, 2020

How does the FDA determine if a drug is safe?

FDA approval of a drug means that data on the drug's effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. Evidence that the drug will benefit the target population should outweigh any risks and uncertainties.

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Then, how does a drug get approved by the FDA?

In the United States, the FDA approves drugs. Drug companies seeking to sell a drug in the United States must first test it. The company then sends the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) evidence from these tests to prove the drug is safe and effective for its intended use.

Also, how are drugs tested for safety? A typical test involves giving a known amount of the substance to the animals, then monitoring them carefully for any side-effects. Drugs that have passed animal tests are used in human clinical trials. The substances are then tested on people with the illness to ensure that they are safe and that they work.

Additionally, how does the FDA ensure the safety and effectiveness of drugs?

The Over-the-Counter Drug Review process is established to improve the safety, effectiveness and accurate labeling of drugs sold without a prescription. The Medical Device Amendments passes, allowing the FDA to ensure the safety of medical devices and diagnostic products.

How long does it take for the FDA to approve a drug?

The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe.

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