RE:RE:RE:RE:How does Accelerated Approval work And for those who don't read or understand what has already been posted ...
this was posted on Apr 15, 2024 2:38pm
In the case of Orphan / Rare diseases and in diseases with unmet treatment needs, the FDA appears to have a tendency to grant drug Accelerated Approvals much quicker than otherwise, and they do so in an overall effort to drive patients suffering from these diseases into the registration studies earlier than could happen normally.