Posts with tag Legislation

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Prescribing AI: Contrasting Approaches to AI in Drug Development across the Atlantic
According to a common quip in the U.S. they innovate on the technology front, and the Europeans innovate on the regulatory front. It has been argued that regulating AI with more emphasis on risks than on innovation is a common European theme so far, especially with the AI Act on the horizon. In this context it is interesting to observe and compare how regulatory bodies in the U.S. and Europe position themselves. For the pharmaceutical sector, the U.S. Food and Drug Administration (“FDA”) and the...
October 19, 2023
9 min read
Reform of the EU pharmaceutical legislation: proposals...
This article is part of a series that covers the proposed...
July 10, 2023
4 min read
Proposed reform of the EU pharmaceutical legislation:...
This article is part of a series that covers the proposed...
June 27, 2023
4 min read
Strengthened Environmental Risk Assessment requirements...
This article is part of a series that covers the proposed...
June 23, 2023
3 min read
Revamping the European pharmaceutical industry: A closer look at the EU’s proposed legislative framework
On 26 April 2023, the European Commission published the long-anticipated proposal for the revision of...
April 28, 2023
3 min read
The Windsor Framework: One Step Closer to a Single UK market
Following the coming into force of the Windsor Agreement on 25 March 2023, we take a look at what this...
April 3, 2023
5 min read