As industry looks forward to using the “breakthrough” designation created by the FDA Safety and Innovation Act, a look back at some of the approvals examined in Pharmaceutical Approvals Monthly’s Drug Review Profiles in the past year shows that a few of FDA’s approvals could serve as models for the new process.
Each new PDUFA regime brings efforts to improve the FDA review process, and with the fifth reauthorization industry pushed hard for new pathways to accelerate drug development