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and covering topics from regulatory to business insights.
The latest news from a&r
MDR transition period and deletion of the MDR/IVDR ‘sell-off dates’ officially implemented
Regulation (EU) 2023/607 of the European Parliament and of the Council of 15...
Progress in the authorisation of novel foods and a cholesterol lowering health claim
Latest novel food authorisations In March 2023, the European Commission (EC)...
Botanical extracts are increasingly under pressure due to growing safety concerns
Recently, various botanical preparations derived from traditional ayurvedic...
Novel food status of biotechnically produced sodium hyaluronate clarified in consultation request
The consultation request under Article 4 of Regulation (EU) 2015/2283 concerns...
Advantage for Sponsors to utilize digital subject reporting outcomes (eDiary) in clinical trials
The past couple of years brought new challenges to clinical trials; however,...
EFSA’s work on the update or rather reduction of ULs
EFSA is in the process of revising the safety limits for certain vitamins and...
Impressions of Probiota 2023: Call for harmonisation and need for clinical trials
a&r’s managing director Dr. Volker Schehlmann was delighted to meet...
Medical Device Regulation Extension of transition period approved, but what are the implications?
In recent months, news about the Medical Device Regulation has accumulated....
First Novel food approval for insects in supplements
6 successful applications of insects as Novel Food, authorised by the EC as a novel food for sale in food supplements.
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