MoFo Life Sciences

January 24, 2023 - FDA, Regulatory, United States, COVID-19, Medical Devices + Diagnostics
FDA Updates COVID-19 Testing Guidances
By: Brigid DeCoursey Bondoc
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
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: Brigid DeCoursey Bondoc 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 12, 2023 - FDA, Regulatory, United States
Congress Expands FDA Authority Over Cosmetics
By: Brigid DeCoursey Bondoc 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: Brigid DeCoursey Bondoc
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 16, 2022 - AI + Robotics, FDA, Regulatory
AI Trends for 2023 - FDA Regulatory
In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program. The new FDA policies move away from prized flexibilities in the previous guidelines governing software products.
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December 14, 2022 - Intellectual Property, Pharma, Regulatory, European Union
Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers
By: Robert Grohmann
In two recent landmark decisions, Novartis v. Abacus (C ‑ 147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union ( CJEU ) strengthened the position of drug manufacturers against repackaging practices of parallel importers. The court held that, based
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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
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 Ph.D., Christopher D Lew, Abby C. Burrus Ph.D. and Michael Ward Ph.D.
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: Mehran Arjomand and Jean Nguyen Ph.D.
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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Topic Archives: Regulatory

FDA Updates COVID-19 Testing Guidances

By: Brigid DeCoursey Bondoc

CMS Reveals New Details on Medicare Drug Price Negotiation Program

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

By: Brigid DeCoursey Bondoc and Kate Driscoll

Congress Expands FDA Authority Over Cosmetics

By: Brigid DeCoursey Bondoc and Matt Robinson

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

By: Brigid DeCoursey Bondoc

AI Trends for 2023 - FDA Regulatory

Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers

By: Robert Grohmann

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

USDA’s PVP System Embraces Transgenic and Gene Edited Plants

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

The USPTO and the FDA Join Hands to Promote Competition

By: Mehran Arjomand and Jean Nguyen Ph.D.