Personalized Medicine Provides ‘Viable’ Model for Drug Development: FDA Report

A new FDA report outlining the agency’s efforts to regulate drug development in the context of personalized medicine promotes the approach as a boon for both innovation and patient safety. The report, released Tuesday, notes that since 2011, about a third of newly approved drugs used some type of genetic or other biomarker data in the drug submission to characterize efficacy, safety or pharmacokinetics — tools intrinsic to advancing the promise of personalized medicine.
Drug Industry Daily