FDA: Rigorous Trials Needed for Accelerated Approval

Published on March 24, 2023

Imagine you’re trying to win a race. You might think that taking a shortcut would be the quickest way to reach the finish line. But according to the U.S. health regulator, that’s not always the case when it comes to approving cancer drugs. The Food and Drug Administration (FDA) has proposed that developers of cancer drugs should conduct more rigorous trials in order to seek accelerated approval for their candidates. This recommendation comes after criticism of the current system, which allows drugs to be approved based on less conclusive evidence. It’s like saying you’ve won the race without actually crossing the finish line! By implementing stricter trial requirements, the FDA hopes to ensure that only safe and effective drugs are granted accelerated approval. It’s kind of like having a rule that says you can only claim victory if you’ve completed the entire race course. While this may slow down the drug development process, it could lead to more accurate assessments of a drug’s benefits and risks. If you want to learn more about this proposal and its potential impact on cancer drug development, check out the underlying research!

The U.S. health regulator on Friday proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates. The Food and Drug Administration’s proposed recommendation follows criticism for the accelerated approval…

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