MoFo Life Sciences

November 16, 2021 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Digital Health
Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference
By: Stacy Cline Amin and Rachel Park
The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond , November 9-10, 2021. Morrison & Foerster’s Stacy Cline Amin and Bethany Hills led panel discussions during the two-day conference. Stacy Cline Amin, who
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November 01, 2021 - United States, FDA, Medical Devices + Diagnostics, Regulatory
FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development
By: Rachel Park
This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), identified 10 guiding principles to inform the development of Good Machine Learning Practice (GMLP) and promote safe and effective medical
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October 28, 2021 - United States, Intellectual Property
Traversing Higher Hurdles for Functional Limitations Under Section 112
By: Meghan McLean Poon and Kelsey J Roberts Kingman
Genus claims have long been an important component of patent strategy, extending coverage around a lead compound to stop would-be competitors. Recent decisions from the Federal Circuit, however, highlight a tightening standard for written description and enablement of genus claims for biologic inventions, leading
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October 26, 2021 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Healthcare
Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop
By: Rachel Park and Stacy Cline Amin
On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML technology in
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October 25, 2021 - United States, FDA, Rare Disease, Pharma, Regulatory
FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products
By: Rachel Park and Brigid DeCoursey Bondoc
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “ Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations .” The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria
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October 08, 2021 - United States, FDA, Litigation, Pharma, Intellectual Property
Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices
By: Fitz B. Collings
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a “Comprehensive Plan for Addressing High Drug Prices.” The HHS Report—issued
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October 01, 2021 - United States, Healthcare, Privacy + Data Security
Health App and Device Providers Take Note: Health Breach Notification Rule Enforcement Is Coming
By: Melissa M. Crespo
As the mobile health and connected device market continues to grow at an exponential pace, the Federal Trade Commission (“FTC”) has issued a Policy Statement that emphasizes its commitment to ensuring the protection of sensitive information collected by these apps and devices. On September
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September 22, 2021 - United States, FDA, Healthcare
CMS Proposes to Repeal MCIT Final Rule
Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule (the “Proposed Rule”), which CMS published on January 14, 2021 in the waning
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September 15, 2021 - United States, COVID-19, Healthcare, Pharma
Is the Future of Telehealth in OIG’s Hands?
Telehealth services may be at a crossroads. While the COVID-19 pandemic brought about widespread adoption of telehealth services, the Department of Justice and the U.S. Department of Health and Human Services Office of Inspector General (OIG) appear primed to audit telehealth services and ramp
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July 26, 2021 - United States, FDA, Healthcare
Cures 2.0: Will It Be Better Than the Original?
By: Stacy Cline Amin
It’s summer blockbuster season and that means sequels abound. Now it seems that the U.S. Congress wants in on the action. Just five years after Congress passed the 21st Century Cures Act, a bipartisan group of representatives is looking to enact follow-up legislation—“Cures 2.0.”
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