| Literature DB >> 28496147 |
Nina L Hunter1, Rachel E Sherman1.
Abstract
New opportunities to develop innovative - and often complex - products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible and consistent science-based regulatory approach for combination products.Mesh:
Year: 2017 PMID: 28496147 DOI: 10.1038/nrd.2017.66
Source DB: PubMed Journal: Nat Rev Drug Discov ISSN: 1474-1776 Impact factor: 84.694