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 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
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 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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October 18, 2022 - FDA, Digital Health, Healthcare
Telehealth Fraud Enforcement: Trends, Predictions, and Best Practices
By: Kate Driscoll
Morrison Foerster's Kate Driscoll joined the American Bar Association Health Law Section "Voices in Health Law" podcast to discuss the latest telehealth enforcement trends. The rise of telehealth services during the COVID-19 pandemic resulted in new and adapted forms of fraud, and Kate offers
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October 04, 2022 - FDA, Product Liability + Class Action
Water Is in, White Bread Is Out: “Healthy” Gets a New Look in 2023
By: Claudia M. Vetesi, Lena Gankin and Nick R. Dyess
For decades, health-conscious consumers have argued about what it really means for a food to be “healthy.” Is dark chocolate “healthy”? How about breakfast cereal, coffee, or fruit gummies? At the same time, class action litigants have seized on ever-evolving and subjective definitions of “healthy,” pursuing claims
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