Alternative Protein - A Comparison of the Regulation of Insect Protein as Food and Feed
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- - AgtechThis article follows our introduction to the alternative protein industry and the legal considerations for companies and investors operating within it. The focus of this article is on the regulation of insects as food and feed in the European Union (“EU”), United Kingdom (“UK”),... ›
Traversing Higher Hurdles for Functional Limitations Under Section 112
By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.
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... ›Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop
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By: Brigid DeCoursey Bondoc
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10/27/2021 Update : The adopted regulation ((EU) 2021/1873) is now officially published in the Journal of the EU. In accordance with the vote of the Council of the European Union on October 5, 2021, the European Union has adopted a new regulation aimed at... ›Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices
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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... ›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... ›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... ›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.”... ›