Document Type

Brief

Publication Date

2011

Abstract

This brief reviews regulatory guidance documents and how they may apply to multi-purpose technologies (MPTs). It examines guidance documents from the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The brief concludes by anticipating increased interactions with US regulatory agencies in hopes of finding new regulatory pathways that address MPTs specifically.

DOI

doi.org/10.31899/hiv1.1011

Language

English

Share

COinS