The impact of parallel regulatory-HTA scientific advice on clinical development. Assessing the uptake of regulatory and HTA recommendations.

Author
:
G Tafuri
I Lucas
S Estevão
J Moseley
A d'Andon
H Bruehl
E Gajraj
S Garcia
N Hedberg
M Massari
A Molina
M Obach
L Osipenko
F Petavy
M Petschulies
C Pontes
P Russo
A Schiel
M Van de Casteele
EM Zebedin-Brandl
G Rasi
S Vamvakas
Abstract
:

The "Parallel regulatory-HTA SA" (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and HTA bodies on development plans for new medicines.
Year of Publication
:
2018
Journal
:
British journal of clinical pharmacology
Date Published
:
2018
ISSN Number
:
0306-5251
URL
:
http://dx.doi.org/10.1111/bcp.13524
DOI
:
10.1111/bcp.13524
Short Title
:
Br J Clin Pharmacol
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