MoFo Life Sciences

March 03, 2020 - United States, FDA, COVID-19, Healthcare
FDA Working to Address 2019 Novel Coronavirus (COVID-19): Supply Chain (Part II)
FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and supporting emergency efforts to diagnose and treat the disease. In addition,
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March 02, 2020 - United States, FDA, COVID-19, Healthcare, Asia
FDA Working to Address 2019 Novel Coronavirus (COVID-19): Product Safety (Part I)
FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and supporting emergency efforts to diagnose and treat the disease. In addition,
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February 27, 2020 - United States, FDA, Agtech, Litigation, Privacy + Data Security
January FDA Updates
As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and product development issues every month. Our January recap is below. 1. FDA, USDA and EPA announce joint platform to streamline information
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February 20, 2020 - United States, Intellectual Property
New USPTO Rule Likely to Increase Spam
By: Muzamil Huq
The United States Patent and Trademark Office (USPTO) just issued new rules that directly affect trademark owners. Going forward, trademark applicants, registrants, and parties to a proceeding before the Trademark Trial and Appeal Board will need to provide their email address in USPTO filings.
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January 23, 2020 - United States, FDA, Biotech, Healthcare, Pharma, Regulatory, Cell + Gene Therapy
FDA and Real-World Evidence in 2019
Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the agency in evaluating the potential use of real-world evidence (RWE) in regulatory decisions involving drug and biological products.[2] The
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January 23, 2020 - United States, Agtech, Regulatory, Intellectual Property
Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants
By: Liz Freeman Rosenzweig Ph.D., Cory Ellison Ph.D. and Michael Ward Ph.D.
On January 6, 2020, the Plant Variety Protection Office (PVPO) released the final version of its much-anticipated rule to open Plant Variety Protection (PVP) to asexually reproduced plants. Publication of this rule means that the PVPO is now accepting applications for all species of
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January 21, 2020 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Healthcare
Digital Health in 2019
The year 2019 saw relatively few developments in the digital health space. Although progress has been slow, FDA did make headway on two initiatives: (1) addressing the unique challenges of regulating artificial intelligence and machine learning (AI/ML) in medical applications, and (2) implementing changes
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January 15, 2020 - United States, FDA, Announcements
2020 Under Dr. Stephen Hahn, FDA’s New Commissioner
By: Julie Y. Park
Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17 vote. Hahn became the fourth leader of FDA in 2019 and the first confirmed nominee since
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January 10, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 3)
Our earlier posts ( part 1 and part 2 ) looked at a few overall trends at FDA as well as the impact of consent decrees issued in 2019. Today we will highlight some enforcement trends at the Department of Justice. Department of Justice
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January 09, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 2)
Yesterday , we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our series, we look at the specifics of FDA’s 2019 consent decrees. FDA Consent Decrees FDA published
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Topic Archives: United States

FDA Working to Address 2019 Novel Coronavirus (COVID-19): Supply Chain (Part II)

FDA Working to Address 2019 Novel Coronavirus (COVID-19): Product Safety (Part I)

January FDA Updates

New USPTO Rule Likely to Increase Spam

By: Muzamil Huq

FDA and Real-World Evidence in 2019

Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants

By: Liz Freeman Rosenzweig Ph.D., Cory Ellison Ph.D. and Michael Ward Ph.D.

Digital Health in 2019

2020 Under Dr. Stephen Hahn, FDA’s New Commissioner

By: Julie Y. Park

2019 FDA Enforcement and Related Litigation Trends (Part 3)

2019 FDA Enforcement and Related Litigation Trends (Part 2)