MoFo Life Sciences

March 18, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Biotech, Healthcare, Pharma
FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers
On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health
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March 12, 2020 - United States, COVID-19, Healthcare, Privacy + Data Security
OCR Bulletin on HIPAA Privacy and Coronavirus (COVID-19)
By: Melissa M. Crespo
In response to the recent outbreak of the novel coronavirus (2019-nCoV or COVID-19) and associated preparation and response, the Department of Health and Human Services Office for Civil Rights (OCR) recently released a bulletin (the “Bulletin”) outlining how entities subject to HIPAA may share
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March 11, 2020 - United States, Medical Devices + Diagnostics, COVID-19, Biotech, Healthcare, Pharma
U.S. government announces new federal funding opportunities related to COVID-19
By: Tina D. Reynolds
The Biomedical Advanced Research and Development Authority ( BARDA ), part of the U.S Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, has modified an existing broad agency announcement (BAA) through which it will award government funding
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March 05, 2020 - United States, FDA, COVID-19, Healthcare
FDA Working to Address 2019 Novel Coronavirus (COVID-19): Diagnosis & Treatment (Part III)
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 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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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 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 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: Healthcare

FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers

OCR Bulletin on HIPAA Privacy and Coronavirus (COVID-19)

By: Melissa M. Crespo

U.S. government announces new federal funding opportunities related to COVID-19

By: Tina D. Reynolds

FDA Working to Address 2019 Novel Coronavirus (COVID-19): Diagnosis & Treatment (Part III)

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)

FDA and Real-World Evidence in 2019

Digital Health in 2019

2019 FDA Enforcement and Related Litigation Trends (Part 3)

2019 FDA Enforcement and Related Litigation Trends (Part 2)