Sep 30, 2022 Anvisa’s new rules on the regulation of medical devices - Brazil By Bruna Rocha Juliana Marcondes Victoria Cristofaro As previously shared when the new regulatory framework for software as a medical device (“SaMDs”) was presented earlier this year (here),...
Sep 30, 2022 Italy reintroduces payback systems for medical devices. How can companies act to avoid excessive spending By Giorgia Romitelli Roberta Moffa With Law Decree no. 115/2022 (Aiuti Bis Decree), the Italian Government reactivated the so-called “payback” system for medical devices....
Sep 28, 2022 Deterring pay-for-delay: Juno Pharmaceuticals Pty Ltd & Ors By Chantal Encavey In March this year the pharmaceutical companies Juno Pharmaceuticals Pty Ltd (Juno), Natco Pharma Ltd (Natco), and Celgene Corporation...
Sep 27, 2022 Bioeconomy Executive Order: A whole-of-government approach to advancing biotechnology and biomanufacturing By Jamie Gregorian Bethany Hills Alex Pinson Matthew Larson +1 more... Show less President Joe Biden has issued an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and...
Sep 26, 2022 The Polish government plans to change the legal regulations regarding dietary supplements By Andrzej Balicki, Ph.D. Jolanta Dabrowicz The Polish government plans to change the legal regulations regarding dietary supplements. The government's adoption of the draft...
Sep 23, 2022 Interchangeability of biosimilar medicines confirmed by EMA and HMA By Mariana Ricardo The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement on the interchangeability of...
Sep 23, 2022 Regulate your thoughts: the age of brain-machine interfaces and the neural lace is almost here By Coran Darling Keo Shaw Gareth Stokes You wake up early to the sound of an alarm that only exists inside your own head, and it is silenced automatically as soon as you’re...
Sep 20, 2022 Italian adapts national medical device framework to MDR and IVDR By Marco de Morpurgo Carlotta Busani Italy enacted legislation to adapt the national framework governing medical devices and in vitro-diagnostic medical devices to the MDR...
Sep 20, 2022 Genetic information – global privacy considerations – an Australian and UK perspective By James Clark Sarah Birkett Senal Premarathna Introduction The benefits of using genetic information for research purposes are clear, especially as the technology underpinning...
Sep 15, 2022 AI risk assessments: Future-proofing your innovation when rules can change mid-game - At the Intersection of Science and Law Podcast Series By Danny Tobey In this episode, DLA Piper partner Danny Tobey is joined by Aviva Wein, Assistant General Counsel at Johnson & Johnson, to discuss how...
Sep 07, 2022 Hear ye, hear ye! FDA finalizes OTC hearing aids rule and issues updated guidance on personal sound amplification products By Keo Shaw Christopher Mikson Matthew Piscitelli In a paradigm shift for the hearing aid industry and patients, the FDA has finalized a rule to establish a new over-the-counter (OTC)...
Sep 02, 2022 Expedite patent examination for foreign applicants in Brazil By Domiciano Sá The Brazilian Patent and Trademark Office (BRPTO) efforts to reduce the patent backlog is generating positive results despite the...
Sep 01, 2022 ANVISA speeds up public health measures to fight against monkeypox By Bruna Rocha Juliana Marcondes Victoria Cristofaro Brazil currently has the third most cases of monkeypox in the world. Until August 20 of this year, 14,054 notifications were registered...