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Portolano Cavallo Life Sciences Blog
5 Oct 22
Observational studies: From the November 30, 2021 Decree to the new document of the National Coordination Center for Ethics Committees
Pharmacological observational studies concern drugs prescribed according to an authorized therapeutic indication and based on normal clinical practice.
5 Oct 22
<!--:it-->European Health Data Space: Early indications of the future of circulation of health information in the European Union<!--:-->
The establishment of a European Health Data Space sits within the broader framework of the strategy developed by European institutions to create a single market for data.
5 Oct 22
Payback mechanism for medical devices in light of the Aiuti-bis Decree
On September 22, Law No. 142/2022 converting Decree-Law No. 115 of August 9, 2022 (the “Aiuti-bis Decree”) was published.
5 Oct 22
The new standards for territorial care and telemedicine services in accordance with Ministerial Decree 77/2022
On June 22, 2022, the decree of the Ministry of Health No. 77 on “Models and standards for the development of territorial care in the National Health Service” (the “Document”) was published in the Official Gazette.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
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