Towards a better use of scientific advice for developers of advanced therapies.

Abstract:

:Scientific advice (SA) is an important tool offered by regulators to help developers generate robust evidence on a medicine's benefits and risks. Drawing on accumulated experience and looking at the SA provided by the European Medicines Agency in 2018 to advanced therapy medicinal products originally developed by public bodies, we discuss most commonly raised issues and the complexity and timings of the questions posed. Earlier and more frequent SA could help advanced therapy medicinal product developers to pre-empt delays at the marketing authorisation stage. Carefully addressing quality and nonclinical issues before entering the pivotal phase of development will clear the path for a smooth clinical development and successful marketing authorisation.

journal_name

Br J Clin Pharmacol

authors

Tavridou A,Rogers D,Bonelli M,Schiel A,Hidalgo-Simon A

doi

10.1111/bcp.14672

subject

Has Abstract

pub_date

2020-11-25 00:00:00

eissn

0306-5251

issn

1365-2125

pub_type

杂志文章
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