Biotech Values

[DewDiligence]

Re: Proposed changes in requirements for Accelerated Approval

The committee debated whether a randomized, two-arm trial rather than a single-arm trial should be required in certain accelerated approval cases. The committee also discussed whether a minimum of two post-marketing trials is necessary and whether accelerated approval should be delayed until the confirmatory trials are actually underway. Ideally, the FDA Office of Oncology would like drug makers to have confirmatory trials underway, with set completion dates, at the time of accelerated approval.

If the rule in bolded text were formally adopted, it would significantly slow down accelerated-approval timelines. However, this seems like a good way of closing a huge loophole in the current way of doing things.