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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.


Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 3 of 6)

Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in part 2 of our series of articles, in this part …›

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6)

In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed further light on the expansion of the definition …›

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 1 of 6)

The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this trend is likely to continue. As with every health-related product or …›

January 27, 2021 - COVID-19, Employment

Podcast: COVID-19 Vaccines in the Workplace

In this fifth episode of our podcast series on COVID-19, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses with Janie Schulman, employment and labor partner in our Los Angeles office as well as co-chair of …›

Top 10 Considerations When Drafting and Negotiating SRAs, with U.S. and EU Perspectives

Sponsored Research Agreements (SRA) are used by companies to contract a research organization, such as a university, to conduct research and development activities in exchange for fees and the university’s rights to use the results for general research purposes. Care should be taken to …›

FDA’s Covid-19 Product Regulation Enforcement Roadmap

Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA …›