Good News For Sponsors Of Combination Studies Involving Both Drugs And IVD Medical Devices
| Published date | 29 January 2024 |
| Law Firm | Plesner |
| Author | Mette-Marie Buch Henrichsen |
A new application process and accompanying guidance will hopefully make it easier to get started with such studies.
The Danish Medicines Agency and the Danish Committees on Scientific Ethics have jointly prepared a new guidance for a new national coordinated application process for clinical trials of medicinal products and performance studies for in vitro diagnostic devices (IVD) in combination studies.
So far, the Sponsor has had to go through separate application processes for (a) authorisation for the...
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