MoFo Life Sciences

January 17, 2023 - FDA, Regulatory, United States, Pharma
FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS
By: Stacy Cline Amin, Brigid DeCoursey Bondoc, Rachel Park and Kate Driscoll
On January 3, 2023, the U.S. Food & Drug Administration (FDA) modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program to remove the in-person dispensing requirement and allow dispensing of mifepristone at certified retail pharmacies. FDA announced this forthcoming modification in December 2021
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January 17, 2023 - Bioinformatics, Litigation, United States, Data Analytics
Privacy Litigation 2022 Year in Review: Biometric Information Privacy Act (BIPA)
By: Tiffany Cheung
In 2022, Illinois’s Biometric Information Privacy Act (BIPA) litigation was bustling. Defendants in BIPA cases ranged from pharmacies, insurance companies, and social media platforms to software companies, schools, and airlines. Even with the steady stream of opinions in 2022, key questions about BIPA’s scope
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January 12, 2023 - FDA, Regulatory, United States
Congress Expands FDA Authority Over Cosmetics
By: Stacy Cline Amin, Brigid DeCoursey Bondoc, Rachel Park and Matt Robinson
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug Administration (FDA) significant new authority to regulate cosmetics.
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January 11, 2023 - FDA, Regulatory, United States, Medical Devices + Diagnostics
FDA Clarifies the Human Factors or Usability Information to Include in a Device Marketing Submission
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Keunbong (KB) Do
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing
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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 and Rachel Park
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, Christopher D Lew, Abby C. Burrus and Michael R. Ward
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
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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Topic Archives: United States

FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS

By: Stacy Cline Amin, Brigid DeCoursey Bondoc, Rachel Park and Kate Driscoll

Privacy Litigation 2022 Year in Review: Biometric Information Privacy Act (BIPA)

By: Tiffany Cheung

Congress Expands FDA Authority Over Cosmetics

By: Stacy Cline Amin, Brigid DeCoursey Bondoc, Rachel Park and Matt Robinson

FDA Clarifies the Human Factors or Usability Information to Include in a Device Marketing Submission

By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Keunbong (KB) Do

FDA Final Food Traceability Rule: Overview and Key Takeaways from FDA’s Food Safety Modernization Act Webinar

By: Stacy Cline Amin and Rachel Park

USDA’s PVP System Embraces Transgenic and Gene Edited Plants

By: Liz Freeman Rosenzweig, Christopher D Lew, Abby C. Burrus and Michael R. Ward

The USPTO and the FDA Join Hands to Promote Competition

By: Stacy Cline Amin, Mehran Arjomand and Jean Nguyen

CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies

By: Wendy C. Chow

U.S. Government Launches Billion-Dollar Biomedical Agency

By: Tina D. Reynolds

Sawing Through Patent Term—the Federal Circuit’s Recent Decision In Sawstop

By: Mehran Arjomand and Meghan McLean Poon