Posts with tag Healthcare

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Single-arm clinical trials: EMA launches consultation
In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively simple by design: a sample of individuals receive an experimental treatment for a targeted condition, and are followed over a period of time to observe and evaluate their response to the treatment. RCTs are the gold standard when it comes to evaluating the efficacy of a new treatment, and are vital for marketing authorisation (MA) applications. However, in a distinct subset of MA applications, efficacy...
April 26, 2023
2 min read
The Netherlands: Tolerance policy on online prescribing...
On 11 April 2023, the Dutch Ministry of Health, Welfare and Sport...
April 24, 2023
3 min read
LFSS 2023: creation of a new accreditation system for...
Article 53 of the Social Security Financing Act for 2023 (LFSS)...
February 21, 2023
2 min read
The Impact of the NIS2 Directive and the CER Directive for Medical Device Manufacturers and the Healthcare Sector
The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased...
February 17, 2023
9 min read
Cannabidiol (CBD): Annulment of the order prohibiting the sale of cannabis flowers and leaves
The Council of State (Conseil d’Etat) has recently annulled the government order prohibiting the sale...
January 13, 2023
2 min read
UK Supreme Court to assess plausibility of anaemia patents
The UK Supreme Court has just confirmed that it will hear the appeal in FibroGen Inc v Akebia Th...
December 23, 2022
3 min read
The Legal 500: Pharmaceutical Advertising Comparative Guide 2022
The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online. The...
December 12, 2022
1 min read
Rebranding generics as branded medicines – CJEU issues new guidance
The CJEU has provided welcome new guidance on when parallel importers can rebrand generic medicines with...
December 9, 2022
5 min read
Dialogue at EU level on the legalisation of recreational cannabis – the German Federal Government’s White Paper will not suffice
The Federal Government submits its White Paper on the legalisation of recreational cannabis to the...
December 1, 2022
11 min read
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