MoFo Life Sciences

December 16, 2021 - AI + Robotics, Medical Devices + Diagnostics, Digital Health, Regulatory
AI TRENDS FOR 2022 - FDA REGULATORY
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework. In 2021, FDA published the AI and Machine Learning Software as
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December 15, 2021 - Global, Agtech, Regulatory
“At any rate, it won’t fail because of money.”
By: Wolfgang Schönig
In an interview with Sabine Wadewitz, life sciences expert Wolfgang Schönig talks about the details of CO²-neutral meat production, the legal framework conditions, and the latest developments in the industry. Excerpt below. _____________________________________________ Dr. Schönig, CO2-neutral meat production is considered one of the key
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November 01, 2021 - United States, FDA, Medical Devices + Diagnostics, Regulatory
FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development
This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), identified 10 guiding principles to inform the development of Good Machine Learning Practice (GMLP) and promote safe and effective medical
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October 25, 2021 - United States, FDA, Rare Disease, Pharma, Regulatory, Cell + Gene Therapy
FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products
By: Brigid DeCoursey Bondoc
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “ Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations .” The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria
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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 Ph.D. and David H. Kaufman
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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Topic Archives: Regulatory

AI TRENDS FOR 2022 - FDA REGULATORY

“At any rate, it won’t fail because of money.”

By: Wolfgang Schönig

FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development

FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

By: Brigid DeCoursey Bondoc

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 Ph.D. and David H. Kaufman

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