Posted by Michael Wonder on 29 Nov 2016
Improving the accelerated pathway to cancer drug approvals
29 November 2016 - The US FDA must balance the need to bring potentially lifesaving drugs to market with the need to ensure the safety and effectiveness of these drugs.
To balance these competing goals, the FDA has increasingly used the accelerated pathway, which is meant for drugs that treat serious conditions and fill an unmet medical need. Approval is based on a surrogate or an early clinical endpoint and is conditional on the completion of confirmatory trials, which are planned prior to the approval process.
