MoFo Life Sciences

February 06, 2023 - Healthcare, Litigation, Antitrust, United States
DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing
By: Alexander Okuliar, Lisa M. Phelan, Joseph Charles Folio III, Margaret A. Webb and Jamis Barcott
On February 2, 2023, the Principal Deputy Assistant Attorney General for the U.S. Department of Justice’s (DOJ) Antitrust Division, Doha Mekki, announced that the DOJ was withdrawing three policy statements outlining safe harbors for information sharing in the healthcare industry, and suggested that DOJ’s
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January 30, 2023 - FDA, Regulatory, United States, Healthcare, Medical Devices + Diagnostics, Pharma
FTC Issues Updated Health Products Claims Guidance
By: Stacy Cline Amin, Julie Y. Park, Brigid DeCoursey Bondoc and Matt Robinson
On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The
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January 24, 2023 - FDA, Regulatory, United States, COVID-19, Medical Devices + Diagnostics
FDA Updates COVID-19 Testing Guidances
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. UPDATE : The Executive Office of the President announced on January 30, 2023, that the current administration plans to terminate the PHE declaration on May 11, 2023. This announcement does
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January 20, 2023 - Healthcare, United States, Pharma, Litigation, Regulatory
CMS Reveals New Details on Medicare Drug Price Negotiation Program
By: Wendy C. Chow and Joe Adamczyk
For the first time in history, the Centers for Medicare and Medicaid Services (CMS) will engage in price negotiations with drug manufacturers for a subset of high-cost, name-brand drugs covered by Medicare. Pursuant to the Inflation Reduction Act (IRA), CMS took its first steps
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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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Topic Archives: United States

DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing

By: Alexander Okuliar, Lisa M. Phelan, Joseph Charles Folio III, Margaret A. Webb and Jamis Barcott

FTC Issues Updated Health Products Claims Guidance

By: Stacy Cline Amin, Julie Y. Park, Brigid DeCoursey Bondoc and Matt Robinson

FDA Updates COVID-19 Testing Guidances

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

CMS Reveals New Details on Medicare Drug Price Negotiation Program

By: Wendy C. Chow and Joe Adamczyk

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