MoFo Life Sciences

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
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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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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October 05, 2022 - Intellectual Property, United States
Sawing Through Patent Term—the Federal Circuit’s Recent Decision In Sawstop
By: Mehran Arjomand and Meghan McLean Poon
Patent Term Adjustment (PTA) is additional patent term for U.S. patents to compensate for delay in issuance. The statute (35 U.S.C. § 154(b)) provides three bases for PTA: delayed response by the USPTO (“A delay”), failure to issue a patent within three years (“B delay”),
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September 30, 2022 - United States, Healthcare
A Day Late and a Dollar Short: AAG Polite Warns That Corporate Leaders Who Fail to Invest in Compliance “Early and Often” Do So “At Their Own Risk”
By: Nathaniel R. Mendell, Brian R. Michael, Christine Y. Wong, Kate Driscoll and Mitchell E. Feldman
On September 28, 2022, the Assistant Attorney General for the Criminal Division of the United States Department of Justice (DOJ) joined the Inspector General for the United States Department of Health and Human Services (HHS-OIG) to offer some stern advice for corporate leaders and
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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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September 28, 2022 - FDA, Healthcare, Medical Devices + Diagnostics, Regulatory, United States
FDA Releases Foundational Digital Health Guidance
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On September 27, 2022, the U.S. Food and Drug Administration (FDA) issued its long-awaited final clinical decision support (CDS) software function guidance. This final guidance presents a significant departure from the previous draft version issued three years prior, including updates to address concerns voiced
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September 23, 2022 - Healthcare, FDA, Regulatory, Medical Devices + Diagnostics, United States
New Opportunities for Test Developers: Monkeypox Diagnostics
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. However, test developers must act fast. The Food and Drug Administration is
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September 12, 2022 - Agtech, Regulatory, United States, Intellectual Property
Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process
By: Liz Freeman Rosenzweig
On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered plant under the SECURE rule. APHIS concluded that a new genetically engineered tomato
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May 26, 2022 - United States, FDA, Healthcare, Pharma, Regulatory, Intellectual Property
Senators Call for Report on State of Psychedelic Research
By: Stacy Cline Amin
Thanks to our Life Sciences Transactions + Licensing Group, including Matthew Karlyn, Mai Zymaris, and Hannah Koo, for contributing to this post. Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and
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