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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.

January 05, 2022 - Litigation, Biotech, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
Life Sciences Patent Trends in 2022 – Doctrine of Equivalents
By: Meghan McLean Poon Ph.D.
The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting patent applicants in the position of having to pursue narrow claims directed to specific sequences. At the same time, reliance on the
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December 23, 2021 - FDA, Medical Devices + Diagnostics, Litigation, Healthcare
3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session
FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021. The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022. The session included presentations from Ann Oxenham (CFSAN),
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December 23, 2021 - FDA, COVID-19, Healthcare, Pharma
Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the Consumer Protection Branch in 2021, and highlighted areas of
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December 22, 2021 - FDA, Healthcare
What New FDA Policy Means for COVID Tests and Beyond
By: Stacy Cline Amin
Stacy Amin and Bethany Hills, co-chairs of our FDA Regulatory + Compliance practice, authored an article for Law360 discussing the U.S. Department of Health and Human Services (HHS) withdrawing a controversial Trump administration policy that prohibited the U.S. Food and Drug Administration (FDA) from requiring
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December 20, 2021 - FDA, Medical Devices + Diagnostics
De Novo Classification Final Rule to Take Effect Next Year
By: Brigid DeCoursey Bondoc
On Tuesday, December 14, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar discussing the final rule , Medical Device De Novo Classification Process, and associated guidance document updates. The final rule, which will take effect on January 3, 2022, codifies the
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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. Read the full article , translated from the original German version. _____________________________________________
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November 30, 2021 - United States, FDA, Healthcare
Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As we reported in an earlier blog post , CMS first proposed
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November 19, 2021 - FDA
HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug Administration (FDA) from requiring a premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations
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November 18, 2021 - AI + Robotics, United States, FDA, Digital Health
Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space
By: Stacy Cline Amin
FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was the panel on “FDA’s Digital Health Center of Excellence: Working with the FDA on Digital Health.” The panel featured Bakul
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