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Welcome to Mofo Life Sciences

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.

February 07, 2023 - FDA, Regulatory, Pharma, Healthcare, United States
Supreme Court Denies Review of Cost Sharing Assistance Program
By: Stacy Cline Amin, Adam L. Braverman, Wendy C. Chow, Will Baker and Seth W. Lloyd
The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible Medicare patients who need tafamidis, the only approved drug by the Food
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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 18, 2023 - European Union, Medical Devices + Diagnostics
EU MDR and IVDR Implementation: European Commission Publishes Full Proposal for Amending Transitional Regime
By: Wolfgang Schönig and Robert Grohmann
Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council ( EPSCO ) Meeting, the European Commission ( Commission ) released on January 6, 2023, a proposal ( Proposal ) to amend the transitional regime under the Medical
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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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Welcome to Mofo Life Sciences

Supreme Court Denies Review of Cost Sharing Assistance Program

By: Stacy Cline Amin, Adam L. Braverman, Wendy C. Chow, Will Baker and Seth W. Lloyd

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

EU MDR and IVDR Implementation: European Commission Publishes Full Proposal for Amending Transitional Regime

By: Wolfgang Schönig and Robert Grohmann

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