MoFo Life Sciences

August 08, 2023 - FDA, Pharma, United States, Healthcare
Medicare Drug Price Negotiation Program Final Guidance
Elena Klonoski, a summer associate in our Boston office, and Lauren Limbach, a summer associate in our Washington, D.C. office, contributed to the drafting of this post. 1. Introduction On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated
... ›
August 02, 2023 - FDA, Regulatory, AI + Robotics, Healthcare
5 Questions About Generative AI in Healthcare
By: Brigid DeCoursey Bondoc
Brigid Bondoc and Wendy Chow authored an article for HealthTech about what the recent growth of generative artificial intelligence (AI) tools means for providers and patients. “In the absence of a clear legal and ethical framework that promotes the complete scope of the benefits
... ›
July 24, 2023 - FDA, Healthcare, Litigation, Pharma, United States
Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures
By: Joseph R. Palmore
In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the Program’s first deadlines. Below we analyze the latest developments in the
... ›
June 15, 2023 - AI + Robotics, Digital Health, FDA, Intellectual Property, Medical Devices + Diagnostics, Privacy + Data Security, Regulatory
The Legal and Regulatory Landscape Evolving with AI in Life Sciences
By: Brigid DeCoursey Bondoc and Anna Yuan
Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion.
... ›
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
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
... ›
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 and Claudia M. Vetesi
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
... ›
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 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
... ›
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: Brigid DeCoursey Bondoc
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)
... ›
March 29, 2023 - Digital Health, FDA, Healthcare, Regulatory, United States
FDA Publishes Digital Health Technology Framework
By: Brigid DeCoursey Bondoc
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
... ›
March 27, 2023 - FDA, Regulatory, Litigation, Product Liability + Class Action, United States
FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives
By: 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,”
... ›

Topic Archives: FDA

Medicare Drug Price Negotiation Program Final Guidance

5 Questions About Generative AI in Healthcare

By: Brigid DeCoursey Bondoc

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

By: Joseph R. Palmore

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

By: Brigid DeCoursey Bondoc and Anna Yuan

FDA on Use of AI/ML in Drug Development: Five Key Takeaways

By: Brigid DeCoursey Bondoc

FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims

By: Brigid DeCoursey Bondoc and Claudia M. Vetesi

FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

By: Brigid DeCoursey Bondoc and Brandy A. Guarda

FDA Issues Final Transition Guidances for COVID-19 Devices

By: Brigid DeCoursey Bondoc

FDA Publishes Digital Health Technology Framework

By: Brigid DeCoursey Bondoc

FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives

By: Brigid DeCoursey Bondoc, William F. Tarantino and Claudia M. Vetesi