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The FDA plans to reduce the amount of data required to start a new drug trial in the US, cutting out most parts that aren’t safety-related, FDA Commissioner Marty Makary told reporters on Wednesday.
The goal is to simplify and expedite the process of applying for an investigational new drug (IND) application, said Makary, who is entering his second year leading the FDA under the Trump administration. It’s a goal supported by drug developers, who have framed these reforms as essential to competing against China’s speedy clinical trial process.
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