The Food and Drug Administration (FDA) is extending the time for public comments on its draft guidance concerning the expedited approval process for drugs and biologics intended for serious conditions. Originally published on December 6, 2024, the comment period has been extended by 30 days, now closing on March 6, 2025. This extension was granted following requests expressing that the initial 60 days were insufficient to provide thorough feedback. The draft guidance aims to streamline the approval pathway for treatments addressing critical health issues.
Simple Explanation
The FDA is giving people more time to say what they think about new rules for quickly approving important medicines, like if you're really sick and need new treatments. They were supposed to finish talking about it by February, but now they have more time until March 6, 2025.