MoFo Life Sciences

October 13, 2021 - Global, Agtech, Regulatory, Intellectual Property
European Union Adopts Regulation to Extend Term of Community Plant Variety Rights in Europe for Varieties of Certain Plant Species
10/27/2021 Update : The adopted regulation ((EU) 2021/1873) is now officially published in the Journal of the EU. In accordance with the vote of the Council of the European Union on October 5, 2021, the European Union has adopted a new regulation aimed at
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May 20, 2021 - United Kingdom, Regulatory
UK’s new emissions trading scheme hosts first auctions
By: Liz Freeman Rosenzweig, David H. Kaufman and Matthew Dunlap
Stephanie Pong , London trainee solicitor contributed to the writing of this article. On January 1, 2021, the UK launched its very own emissions trading scheme (the “UK ETS”) exercising its autonomy since departing the EU. Under this scheme, companies operating in certain sectors
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April 22, 2021 - United States, Digital Health, Healthcare, Regulatory
Is 2021 the Value-Based and Shared Savings Revolution?
By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS regulations, OIG created new safe harbors
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April 13, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 6 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the transition periods certain MDSW can benefit from before
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April 08, 2021 - United States, FDA, Medical Devices + Diagnostics, United Kingdom, European Union, Regulatory
Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap
By: Wolfgang Schönig
On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific
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April 06, 2021 - United States, FDA, Medical Devices + Diagnostics, Regulatory
FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation
In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”) Software Draft Guidance (together the “CDS Draft Guidance”) and the MDR.
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March 24, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of regulation in areas already regulated before. This episode will put the spotlight on
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March 11, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2 ) and the implications of the new risk classification regime (in part 3 ), in this part 4 of our series on Software
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March 03, 2021 - AI + Robotics, United States, FDA, Regulatory
FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS
By: Jean Nguyen
U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to
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March 01, 2021 - FDA, COVID-19, Rare Disease, Biotech, Healthcare, Pharma, Regulatory
Rare Disease: Sustained Progress in Development Regardless of the Pandemic
By: Catherine M. Polizzi
Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In addition, a number of policies implemented in response
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Topic Archives: Regulatory

European Union Adopts Regulation to Extend Term of Community Plant Variety Rights in Europe for Varieties of Certain Plant Species

UK’s new emissions trading scheme hosts first auctions

By: Liz Freeman Rosenzweig, David H. Kaufman and Matthew Dunlap

Is 2021 the Value-Based and Shared Savings Revolution?

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

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap

By: Wolfgang Schönig

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 of 6)

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

By: Jean Nguyen

Rare Disease: Sustained Progress in Development Regardless of the Pandemic

By: Catherine M. Polizzi