MoFo Life Sciences

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 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
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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December 02, 2022 - Healthcare, FDA, Regulatory, Litigation, United States
The USPTO and the FDA Join Hands to Promote Competition
By: Stacy Cline Amin, Mehran Arjomand and Jean Nguyen
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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November 29, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma, United States
CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies
By: Wendy C. Chow
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) published the final 2023 Medicare Physician Fee Schedule (“2023 Fee Schedule”). Although the 2023 Fee Schedule most notably sets the rates for Medicare services for the coming year, the rulemaking also traditionally includes
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November 22, 2022 - FDA, Agtech, Regulatory
FDA Clears the Path to Lab-Grown Meat
By: Stacy Cline Amin, Simon Arlington, Brigid DeCoursey Bondoc and Owen Grayson Hosseinzadeh
Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post. On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken. This
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November 17, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma
FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass
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November 15, 2022 - FDA, Healthcare, Digital Health, Regulatory
Prevent a Clinical Trial from Turning Into a Criminal Trial
By: Stacy Cline Amin, Kate Driscoll, Brian K. Kidd and Brian R. Michael
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” during the
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Topic Archives: Regulatory

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

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

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

The USPTO and the FDA Join Hands to Promote Competition

By: Stacy Cline Amin, Mehran Arjomand and Jean Nguyen

CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies

By: Wendy C. Chow

FDA Clears the Path to Lab-Grown Meat

By: Stacy Cline Amin, Simon Arlington, Brigid DeCoursey Bondoc and Owen Grayson Hosseinzadeh

FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance

By: Stacy Cline Amin and Brigid DeCoursey Bondoc

Prevent a Clinical Trial from Turning Into a Criminal Trial

By: Stacy Cline Amin, Kate Driscoll, Brian K. Kidd and Brian R. Michael