MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.
Starting February 1, 2022, the U.S. Patent and Trademark Office (USPTO) will begin inviting selected applicants to participate in a pilot program to defer subject matter eligibility examination until final disposition of the application or all other rejections have been addressed. The theory behind …›
The increasing presence of data-driven solutions in the healthcare and life sciences sector is apparent from the rise in numbers of patents and patent applications. The number of published bioinformatics patents and patent applications in the last decade has nearly doubled. Bioinformatics …›
The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting patent applicants in the position of having to pursue narrow claims directed to specific sequences. At the same time, reliance on the …›
FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021. The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022. The session included presentations from Ann …›
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the Consumer Protection Branch in 2021, and highlighted areas of …›
Stacy Amin and Bethany Hills, co-chairs of our FDA Regulatory + Compliance practice, authored an article for Law360 discussing the U.S. Department of Health and Human Services (HHS) withdrawing a controversial Trump administration policy that prohibited the U.S. Food and Drug Administration (FDA) from …›
Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post.
On Tuesday, December 14, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar discussing the final rule, Medical Device De Novo Classification Process, and associated …›
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework. In 2021, FDA published the AI and Machine Learning Software …›
In an interview with Sabine Wadewitz, life sciences expert Wolfgang Schönig talks about the details of CO²-neutral meat production, the legal framework conditions, and the latest developments in the industry.
Excerpt below. Read the full article, translated from the original German version.
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Dr. Schönig, CO2-neutral meat …›
Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post.
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable …›
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