A major challenge for regulatory agencies is balancing the need for rapid access to
drugs for new indications against the limited information on their benefit–risk ratio.
The processes described by Martinalbo and colleagues depicted a European scenario
with different national frameworks [
[1]
].Keywords
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Article info
Publication history
Published online: February 03, 2016
Accepted:
January 14,
2016
Received:
January 12,
2016
Identification
Copyright
© 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
