Senators Call for Report on State of Psychedelic Research
- Thanks to our Life Sciences Transactions + Licensing Group, including Matthew Karlyn, Mai Zymaris, and Hannah Koo, for contributing to this post. Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and... ›
RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS
By: Claudia M. Vetesi and Lena Gankin
Originally published by Law360 , Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating the amount... ›FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing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(FDA) issued two draft guidances: “ Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell product development. These draft guidance documents were issued on... ›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 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... ›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.... ›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... ›PATENT TERM EXTENSION FOR BIOLOGICS
By: Meghan McLean Poon and Yuying (Kate) You
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... ›