FDA changes drug approval to one study


FDA changes drug approval to one study

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FDA changes drug approval to one study

The FDA will now ask for only one study to approve new drugs. This is a new rule to make certain medicines available faster.

FDA leaders say modern science makes drug research better and more exact. So, asking for two studies is not always needed in our modern world.

This new rule will mostly help drugs for many common sicknesses. The FDA already approves drugs for rare diseases with just one study.

This change helps FDA reviews become quicker for many new drugs. But the FDA can still ask for more studies for vaccines and other treatments.

The old rule needing two studies began many years ago in the 1960s. This was to make sure drug test results were real and could be repeated.


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What will the FDA now ask for to approve new drugs?

The FDA will now ask for only one study to approve new drugs.

Why is the FDA making this new rule?

This is a new rule to make certain medicines available faster.

When did the old rule needing two studies begin?

The old rule needing two studies began many years ago in the 1960s.


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FDA changes drug approval to one study