Digital technologies for medicines: shaping a framework for success

Regulatory agencies can provide advice to support developers of digital technologies for medicines use, but what are the best strategies to maximize the chance of a successful regulatory interaction? Here, EMA and industry representatives comment on the experience so far. Regulatory agencies can pro...

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Bibliographic Details
Published in:	Nature reviews. Drug discovery Vol. 19; no. 9; pp. 573 - 574
Main Authors:	Cerreta, Francesca, Ritzhaupt, Armin, Metcalfe, Thomas, Askin, Scott, Duarte, João, Berntgen, Michael, Vamvakas, Spiros
Format:	Journal Article
Language:	English
Published:	London Nature Publishing Group UK 01-09-2020 Nature Publishing Group
Subjects:	Biomedicine Biotechnology Cancer Research Clinical trials Comment Decision making Digital technology Drugs Independent regulatory commissions Marketing Medical device industry Medical equipment Medical records Medicinal Chemistry Molecular Medicine Performance management Pharmacology/Toxicology Regulatory agencies Risk assessment Software Technology Validity
Online Access:	Get full text
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Summary:	Regulatory agencies can provide advice to support developers of digital technologies for medicines use, but what are the best strategies to maximize the chance of a successful regulatory interaction? Here, EMA and industry representatives comment on the experience so far. Regulatory agencies can provide advice to support developers of digital technologies for medicines use, but what are the best strategies to maximize the chance of a successful regulatory interaction? Here, EMA and industry representatives comment on the experience so far.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1474-1776 1474-1784
DOI:	10.1038/d41573-020-00080-6