MoFo Life Sciences

December 12, 2022 - Agtech, FDA, Regulatory, United States
FDA Final Food Traceability Rule: Overview and Key Takeaways from FDA’s Food Safety Modernization Act Webinar
By: Stacy Cline Amin
Food Traceability Final Rule Overview On November 21, 2022, the U.S. Food and Drug Administration (FDA) officially published its Final Rule: Requirements for Additional Traceability Records for Certain Foods (“Final Rule”) in the Federal Register. The Final Rule establishes additional traceability recordkeeping requirements for
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December 05, 2022 - Agtech, Regulatory, United States, Intellectual Property
USDA’s PVP System Embraces Transgenic and Gene Edited Plants
By: Liz Freeman Rosenzweig Ph.D., Christopher D Lew, Abby C. Burrus Ph.D. and Michael Ward Ph.D.
This is an excerpt from a longer piece. For more information on the history and landscape of PVPs on transgenic plants, read more. Plant Variety Protection (PVP) is a form of intellectual property protection administered through the United States Department of Agriculture (USDA) for
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December 02, 2022 - Healthcare, FDA, Regulatory, Litigation, United States
The USPTO and the FDA Join Hands to Promote Competition
By: Stacy Cline Amin, Mehran Arjomand and Jean Nguyen Ph.D.
On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). The webinar, entitled “The USPTO‑FDA Collaboration: A Discussion of
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November 29, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma, United States
CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies
By: Wendy C. Chow
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) published the final 2023 Medicare Physician Fee Schedule (“2023 Fee Schedule”). Although the 2023 Fee Schedule most notably sets the rates for Medicare services for the coming year, the rulemaking also traditionally includes
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November 22, 2022 - FDA, Agtech, Regulatory
FDA Clears the Path to Lab-Grown Meat
By: Stacy Cline Amin, Simon Arlington, Brigid DeCoursey Bondoc and Owen Grayson Hosseinzadeh
Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post. On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken. This
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November 17, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma
FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass
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November 15, 2022 - FDA, Healthcare, Digital Health, Regulatory
Prevent a Clinical Trial from Turning Into a Criminal Trial
By: Stacy Cline Amin, Kate Driscoll, Brian K. Kidd and Brian R. Michael
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” during the
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October 28, 2022 - Intellectual Property, Agtech, Regulatory
Germany: Ministry of Health Grants First Glimpse on the Upcoming Cannabis Legalization and Seeks Green Light from the European Commission
By: Robert Grohmann
MoFo research assistant Tim Stripling contributed to this article. In November 2021, in its coalition agreement, the newly elected German Federal Government announced its plans to legalize cannabis for recreational use. Since then, it has been hotly debated by the cannabis industry in Germany
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October 28, 2022 - United States, Healthcare, Regulatory, Digital Health, Biotech
U.S. Government Launches Billion-Dollar Biomedical Agency
By: Tina D. Reynolds
As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). Authorized by Congress in March 2022, the new
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September 28, 2022 - FDA, COVID-19, Healthcare, Medical Devices + Diagnostics, Regulatory, United States
FDA Updates COVID-19 Test Policy
By: Stacy Cline Amin
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency
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