Search Results for keywords:"serious conditions"

The Food and Drug Administration (FDA) has released draft guidance to accelerate the approval process for drugs and biologics meant for serious or life-threatening conditions. This expedited program aims to quickly develop and review drugs that address unmet medical needs. The draft outlines the criteria for accelerated approval, including surrogate endpoints and confirmatory trials, and introduces procedures for rapidly withdrawing approvals if necessary. The public can submit comments on this draft by February 4, 2025, and share thoughts on the expedited withdrawal procedures and other aspects of the accelerated approval process.

The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget (OMB) for review. This collection involves FDA's expedited programs for serious and life-threatening conditions, such as fast track and breakthrough therapy designations, which are designed to speed up the development and marketing of new drugs and biologics. The FDA has issued guidance for sponsors developing these therapies, and is accepting public comments until March 22, 2021. The agency estimates significant effort will be required from participants to prepare necessary documentation, with varying hours needed depending on the type of request.