New drugs are constantly being developed to be better than existing products or to fight new diseases or new strains. Scientists can spend years working on the best formulae, which then have to be rigorously tested to see whether there are any side effects or other complications. Once these processes have been completed, the drugs need to be licensed before they can go on the market.

The time and steps needed to get FDA clearance

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It takes an average of 12 years and many millions of pounds for a new drug to get from the science laboratory to the chemists or hospitals. Companies invest a lot of time and money into developing these new products, including more than three years of testing in the laboratories. An application can then be forwarded to the US Food and Drug Administration (FDA) for tests to be carried out on people. Only one in 1,000 of the products tested in these laboratories will ever make it this far.

Submitting a FDA 510(k)

To market the drug in the US, the company will need to submit a 510(k) to the FDA to demonstrate that the product is safe and effective. Once the product is cleared, it can be marketed. How long does it take to get a FDA 510k approved? If the FDA agrees, there are three phases of clinical trials that take about six years. The company then has to submit an application, which can be as long as 100,000 pages, to the FDA.

Fast-tracking the application

According to Med Device Online, it takes five months on average for a 510(k) submission to be reviewed and cleared. The study by Emergo Group also showed that third-party reviews can pay off because they can speed up the process. This means the product is on the market much quicker, which can be very important if a rival is also bringing out a similar product. For further information about fast-tracking submissions, contact an independent programme such as

After spending so much time and money developing the drug, time is of the essence – the sooner the drug is on the market, the sooner patients get the aid they need and the company can start to recoup its considerable investment.

The 510(k) system was set up by the FDA in 1976 and has cleared more than 140,000 products.

By ZsuNC

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