Last week, the California legislature approved Assembly Bill 418, the California Food Safety Act (AB 418), which is headed to Governor Gavin Newsom to sign or veto by October 14, 2023....more
Last week, the U.S. Department of Agriculture (USDA) issued grants of inspection to two companies, allowing them to begin producing and selling cell-cultivated chicken meat to consumers—a first in the U.S. This marks the end...more
Food Associated Disease Outbreaks -
Food safety in the United States is something that most consumers take for granted. However, there are instances where illness, usually attributed to bacterial infections, can be traced...more
This Client Advisory addresses some frequently asked questions for SARS-CoV-2 diagnostic test developers and provides an overview of recent updates relating to Emergency Use Authorizations (EUAs) published by the U.S. Food...more
In recent days, the U.S. Food and Drug Administration's (FDA's) policy granting authorization to manufacturers and laboratories for desperately-needed COVID-19 test kits has created mass confusion and even led to the...more
Introduction: Citizen Petitions in the News -
Citizen petitions and stay of action petitions (collectively, citizen petitions or petitions) are in the news. Formally, citizen petitions are a mechanism for "interested...more
11/7/2019
/ Abbreviated New Drug Application (ANDA) ,
Administrative Proceedings ,
Anti-Competitive ,
Biosimilars ,
Citizen Petitions ,
Dietary Supplements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Noerr-Pennington Doctrine ,
Public Health ,
Sham Citizen Petitions