FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing
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- 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(FDA) issued two draft guidances: “ Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell product development. These draft guidance documents were issued on... ›
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... ›FDA Clears CRISPR-Edited Cattle for Market Through Abbreviated Procedure: A First for Food-Use Animals
By: Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig Ph.D. and Owen Grayson Hosseinzadeh
Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post. On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that Acceligen Inc. ’s genome-edited, heat-tolerant cattle, pose a “low... ›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... ›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... ›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... ›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... ›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.... ›Quick Guide to JVs in the Alternative Protein Industry
By: Alistair Maughan and Simon Arlington
Investment in the alternative protein industry is surging, and companies are increasingly capitalising on opportunities to partner with each other in this area. Where the partners bring roughly an equal share to the table, these partnerships may be referred to as JVs. JVs are... ›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... ›