MoFo Life Sciences

March 14, 2022 - United States, Healthcare, Pharma, Regulatory
New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy
By: Rachel Park
At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to register, open, and operate a pharmacy within
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March 09, 2022 - Global, FDA, Healthcare, Pharma, Regulatory
FDA’s Loud and Clear Message: Engage with FDA Early and Formally
By: Brigid DeCoursey Bondoc
On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in China. Rather than following the traditional paradigm of assessing the risk-benefit profile
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March 07, 2022 - United States, FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
Quality Management System Regulation (QMSR) – Harmonizing the Quality System Regulation (QSR) with ISO 13485:2016
By: Brigid DeCoursey Bondoc and Rachel Park
Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed rule “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality System Regulation
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February 25, 2022 - United States, FDA, Healthcare, Pharma, Regulatory
Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations
By: Brigid DeCoursey Bondoc and Rachel Park
Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC , a dispute concerning labeling for fluoride products that raised a variety of issues with broader implications for industries regulated by the U.S.
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January 20, 2022 - FDA, Biotech, Healthcare, Pharma, Regulatory
FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products
Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data and real-world evidence into clinical research, product
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December 16, 2021 - AI + Robotics, Medical Devices + Diagnostics, Digital Health, Regulatory
AI TRENDS FOR 2022 - FDA REGULATORY
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 as
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December 15, 2021 - Global, Agtech, Regulatory
“At any rate, it won’t fail because of money.”
By: Wolfgang Schönig
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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November 01, 2021 - United States, FDA, Medical Devices + Diagnostics, Regulatory
FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development
By: Rachel Park
This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), identified 10 guiding principles to inform the development of Good Machine Learning Practice (GMLP) and promote safe and effective medical
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October 25, 2021 - United States, FDA, Rare Disease, Pharma, Regulatory
FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products
By: Rachel Park and Brigid DeCoursey Bondoc
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “ Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations .” The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria
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October 13, 2021 - Global, Agtech, Regulatory, Intellectual Property
European Union Adopts Regulation to Extend Term of Community Plant Variety Rights in Europe for Varieties of Certain Plant Species
10/27/2021 Update : The adopted regulation ((EU) 2021/1873) is now officially published in the Journal of the EU. In accordance with the vote of the Council of the European Union on October 5, 2021, the European Union has adopted a new regulation aimed at
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Topic Archives: Regulatory

New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy

By: Rachel Park

FDA’s Loud and Clear Message: Engage with FDA Early and Formally

By: Brigid DeCoursey Bondoc

Quality Management System Regulation (QMSR) – Harmonizing the Quality System Regulation (QSR) with ISO 13485:2016

By: Brigid DeCoursey Bondoc and Rachel Park

Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations

By: Brigid DeCoursey Bondoc and Rachel Park

FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

AI TRENDS FOR 2022 - FDA REGULATORY

“At any rate, it won’t fail because of money.”

By: Wolfgang Schönig

FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development

By: Rachel Park

FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

By: Rachel Park and Brigid DeCoursey Bondoc

European Union Adopts Regulation to Extend Term of Community Plant Variety Rights in Europe for Varieties of Certain Plant Species