MoFo Life Sciences

May 11, 2023 - AI + Robotics, FDA, Regulatory, Digital Health, United States
FDA on Use of AI/ML in Drug Development: Five Key Takeaways
By: Brigid DeCoursey Bondoc and Rachel Park
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “ Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products .”The discussion paper aims to facilitate a discussion with
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May 03, 2023 - Announcements, Healthcare, Litigation, Regulatory, United States, FDA
FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims
By: Brigid DeCoursey Bondoc, Claudia M. Vetesi and Rachel Park
On April 13, 2023, the Federal Trade Commission (FTC) sent approximately 670 notices of penalty offenses to various companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional foods, placing them on notice that they could incur significant civil penalties
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April 26, 2023 - AI + Robotics, FDA, Medical Devices + Diagnostics, Regulatory, United States
FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions
By: Brigid DeCoursey Bondoc, Rachel Park and Brandy A. Guarda
On April 3, 2023, FDA released the draft guidance titled “ Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions ” (hereinafter “draft guidance”) proposing an approach to support iterative improvement through modifications to a machine
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March 30, 2023 - COVID-19, FDA, Healthcare, Regulatory, Digital Health, Medical Devices + Diagnostics, United States
FDA Issues Final Transition Guidances for COVID-19 Devices
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Keunbong (KB) Do
This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1)
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March 29, 2023 - Digital Health, FDA, Healthcare, Regulatory, United States
FDA Publishes Digital Health Technology Framework
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Rachel Park
On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “ Framework for the Use of Digital Health Technologies in Drug and Biological Product Development ” (Framework) by the Center for Drug Evaluation and Research (CDER) and the
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March 27, 2023 - FDA, Regulatory, Litigation, Product Liability + Class Action, United States
FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives
By: Stacy Cline Amin, Brigid DeCoursey Bondoc, William F. Tarantino and Claudia M. Vetesi
Update 5/1/2023 : FDA is reopening the comment period on the draft guidance published February 23, 2023 (88 FR 11449); the new deadline for comments is July 31, 2023. In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,”
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March 21, 2023 - European Union, FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force
By: Robert Grohmann
On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “ Regulation ”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions
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February 16, 2023 - COVID-19, United States, FDA, Medical Devices + Diagnostics, Healthcare, Pharma
Ending the COVID-19 Public Health Emergency – What Happens Next
By: Stacy Cline Amin, Wendy C. Chow and Keunbong (KB) Do
The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023. COVID-19 EUA medical products and policies As FDA has clarified in its draft transition guidance for medical devices
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February 08, 2023 - FDA, Pharma, Medical Devices + Diagnostics, Rare Disease, United States
FDORA Passage Brings Significant Changes to FDA’s Drug, Device, and Cosmetic Authorities
By: Brigid DeCoursey Bondoc and Rachel Park
The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug, and Cosmetic Act (FDCA) governing drugs, medical
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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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