MoFo Life Sciences

July 22, 2020 - Biotech, Pharma, Regulatory, Asia
China to Criminalize Human Genetic Resources Violations
On June 28, 2020, the draft 11 th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for review. The Draft added a number of crimes intended to “connect” with certain provisions in China’s Human
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July 10, 2020 - Biotech, Pharma, Regulatory, Asia
China’s Biosecurity Law will cover Human Genetic Resources
During its April 2020 meetings, the Standing Committee of China’s National People’s Congress reviewed a number of draft legislations, among which was a draft Biosecurity Law. At the conclusion of the meetings, the second draft of the Biosecurity Law (the “Draft”) was published for
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April 22, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
FDA Uses EUAs Broadly In The Fight Against Covid-19
By: Julie Y. Park
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel
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April 09, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
CARES Act of 2020: Guide for Drug and Device Companies
The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward. The
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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
By: Keunbong (KB) Do
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 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 09, 2020 - FDA, COVID-19, Biotech, Pharma, Blockchain
Blockchain and The Drug Supply Chain Security Act (DSCSA)
As industry continues to grapple with and implement the Drug Supply Chain Security Act (DSCSA) enacted by Congress in 2013, some of the largest pharmaceutical companies believe they may have a solution to track prescription drugs across the supply chain to prevent the distribution
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January 23, 2020 - United States, FDA, Biotech, Healthcare, Pharma, Regulatory
FDA and Real-World Evidence in 2019
By: Keunbong (KB) Do
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 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: Pharma

China to Criminalize Human Genetic Resources Violations

China’s Biosecurity Law will cover Human Genetic Resources

FDA Uses EUAs Broadly In The Fight Against Covid-19

By: Julie Y. Park

CARES Act of 2020: Guide for Drug and Device Companies

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

By: Keunbong (KB) Do

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

By: Tina D. Reynolds

Blockchain and The Drug Supply Chain Security Act (DSCSA)

FDA and Real-World Evidence in 2019

By: Keunbong (KB) Do

2019 FDA Enforcement and Related Litigation Trends (Part 3)

2019 FDA Enforcement and Related Litigation Trends (Part 2)