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Portolano Cavallo Life Sciences Blog
6 Jun 19
Artificial intelligence software: FDA news
On April 2, 2019, a discussion paper describing a proposal for a regulatory framework for modifications to Artificial Intelligence-based medical devices that are already on the market, was published by the Food and Drug Administration (FDA), in view of the future formulation of guidelines that relate to this issue.
5 Jun 19
Breaking news on the supplementary protective certificate for medicinal products
On June 11, 2019, Regulation (EU) 2019/933 (“Regulation 2019/933”), amending Regulation (EC) No 2009/469 (“Regulation 2009/469”) concerning the supplementary protection certificate (“SPC”) for medicinal products, was published in the Official Journal of the European Union.
4 Jun 19
Substitutability of veterinary medicines: this is now also possible through the use of parallel imports
This is a period of profound changes in the veterinary medicines sector.
3 Jun 19
European Law 2018: amendments to the Drugs Code in regard to the implementation of the GMP
On May 26, 2019, Law No. 37 of May 3, 2019 (“European Law 2018 “) entered into force. Article 16 of this law provides for several amendments to Legislative Decree No. 219 of April 24, 2006 (“The Drugs Code“).
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the Life Sciences-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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