Report calls for more openness in FDA fast-track drug approvals
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A new report says the US Food and Drug Administration (FDA) should give clearer information about how it approves some medicines more quickly. This system, called accelerated approval, allows drugs for serious illnesses to reach patients faster by using early test results instead of final proof of benefit.
The policy paper comes from the Institute for Clinical and Economic Review. It says the system has helped bring some important medicines to patients, but there are still problems with delays in follow-up studies and confusion for patients and doctors.
The report suggests several changes. These include better explanations of FDA decisions, stronger rules for evidence, and quicker action if required studies are not finished on time. The report says faster approval must include clear rules and stronger follow-up.
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Vocabulary
6 wordsofficial permission for something to happen
a method or set of connected rules
information showing if something is true
a plan of action by an organisation
Organization that manages or supervises activities.
recommends or offers an idea for consideration
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