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How Does FDA Investigate Proposed New Drugs?

Study looks at all drug approvals between 2005 and 2012.

When the FDA approves a new drug, it's assumed to be safe and effective. But is it safe to make that assumption?
 
A new study examined the FDA approval process for about 200 new drugs over the past several years. Researchers from the Yale University School of Medicine  led a study that examined every FDA drug approval from 2005 to 2012. 

It included how many clinical trials were submitted to support the approval, how long the trials lasted, how many patients were studied and the outcomes used to define the drug's effects and safety.

Researchers say the majority of drugs were studied in high quality clinical trials. A third were approved on the basis of a single trial. It could have been a big trial or a very small one.

Fewer than half were compared to an alternative already avaialble on the market. Also, fewer than half specified for long-term use were studied for more than six months.

Researchers say it's important for patients and physicians to have access to continuously updated information on a drug's performance after it hits the market.

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