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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.

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FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance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On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass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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November 11, 2022 - Agtech, Intellectual Property, Startup, Corporate + Venture Capital
Top Three IP Issues for AgTech Startups
By: Matthew A. Ferry and Edith A. Pierre-Jerome
Innovation, agriculture, and technology took center stage at San Diego’s first AgTech Hackathon. The event took place October 21 – 23 in the city of Escondido, a key farming hub in San Diego County looking to attract agtech startups to the region. The event
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October 28, 2022 - Intellectual Property, Agtech, Regulatory
Germany: Ministry of Health Grants First Glimpse on the Upcoming Cannabis Legalization and Seeks Green Light from the European Commission
By: Robert Grohmann
MoFo research assistant Tim Stripling contributed to this article. In November 2021, in its coalition agreement, the newly elected German Federal Government announced its plans to legalize cannabis for recreational use. Since then, it has been hotly debated by the cannabis industry in Germany
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October 28, 2022 - United States, Healthcare, Regulatory, Digital Health, Biotech
U.S. Government Launches Billion-Dollar Biomedical Agency
By: Tina D. Reynolds
As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). Authorized by Congress in March 2022, the new
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October 25, 2022 - Medical Devices + Diagnostics
Cybersecurity Expectations Intensify for Medical Device Cos.
By: Stacy Cline Amin, Kristen J. Mathews and Josephine A. Garban
Josephine Garban, Patent Agent in New York and San Diego, contributed to this article. Stacy Cline Amin, Kristen Mathews, and Rachel Park co-authored an article for Law360 that discusses the FBI’s private industry notification reminding medical device companies that cybersecurity has to be front
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October 21, 2022 - Agtech, Financing, Startup
Financing Options for an Early Stage Company in the Alternative Protein Industry
By: Simon Arlington and Matthew Dunlap
Having a clear picture of financing options is key for early-stage companies and will be relevant to players in the alternative protein industry generally, given the significant amounts of investment that the industry has seen in recent years (a record US $5bn was invested
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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 05, 2022 - Intellectual Property, United States
Sawing Through Patent Term—the Federal Circuit’s Recent Decision In Sawstop
By: Mehran Arjomand and Meghan McLean Poon
Patent Term Adjustment (PTA) is additional patent term for U.S. patents to compensate for delay in issuance. The statute (35 U.S.C. § 154(b)) provides three bases for PTA: delayed response by the USPTO (“A delay”), failure to issue a patent within three years (“B delay”),
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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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