MoFo Life Sciences

April 07, 2022 - United States, FDA, Healthcare, Regulatory, Cell + Gene Therapy
FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing
By: Brigid DeCoursey Bondoc
On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “ Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell product development. These draft guidance documents were issued on
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April 01, 2022 - FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
QMSR: Welcomed by the Industry, but Lacking in Practicality
By: Brigid DeCoursey Bondoc
On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments." If finalized, the proposed rule will rename the current 21 CFR Part 820 as the
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March 15, 2022 - United States, Litigation, Biotech, Healthcare, Pharma, Intellectual Property
Possession of an "Effective" Dose
By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.
Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit denied Biogen International’s petition for panel rehearing and rehearing en banc , following a November split decision discussed below. Judges Lourie, Moore, and Newman dissented on the denial of en
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March 14, 2022 - United States, Healthcare, Pharma, Regulatory
New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy
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
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
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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February 17, 2022 - FDA, Digital Health, Healthcare
FDA Releases Draft Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
Special thanks to Morrison & Foerster Regulatory Analyst Brandy Guarda for contributing to this article. In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run
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February 15, 2022 - United States, FDA, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
PATENT TERM EXTENSION FOR BIOLOGICS
By: Meghan McLean Poon Ph.D. and Yuying (Kate) You Ph.D.
Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S. Food and Drug Administration (FDA). To be eligible for
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February 09, 2022 - United States, COVID-19, Healthcare
DOJ Releases False Claims Act Statistics for Fiscal Year 2021
By: Brian K. Kidd, Adam L. Braverman and Demme Doufekias
On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it collected more than $5.6 billion in False Claims Act (FCA) settlements and judgments in fiscal year 2021. This is the largest annual total since 2014, and the second largest in FCA history. Though
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Topic Archives: Healthcare

FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing

By: Brigid DeCoursey Bondoc

QMSR: Welcomed by the Industry, but Lacking in Practicality

By: Brigid DeCoursey Bondoc

Possession of an "Effective" Dose

By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.

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

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

Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations

By: Brigid DeCoursey Bondoc

FDA Releases Draft Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

PATENT TERM EXTENSION FOR BIOLOGICS

By: Meghan McLean Poon Ph.D. and Yuying (Kate) You Ph.D.

DOJ Releases False Claims Act Statistics for Fiscal Year 2021

By: Brian K. Kidd, Adam L. Braverman and Demme Doufekias