Posted by Michael Wonder on 08 Nov 2023
FDA finalises guidance on real-time review of oncology drugs
7 November 2023 - The US FDA has finalised its guidance that outlines the eligibility and submission requirements for applicants interested in submitting new drug applications or biologics license applications for its real-time oncology review pilot.
In the final version, the agency rejected calls to expand the guidance to cover cell and gene therapies.
