The programme was created in 1992 to speed access to HIV drugs
NEW YORK – The US Food and Drug Administration’s accelerated approval programme is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients’ lives?
. Today, 85 per cent of accelerated approvals go to cancer drugs. It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. The new study found that between 2013 and 2017, there were 46 cancer drugs granted accelerated approval. Of those, 63pc were converted to regular approval even though only 43pc demonstrated a clinical benefit in confirmatory trials.
US Food And Drug Administration Accelerated Approval Programme FDA HIV Drugs
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