The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more
More than six months into the pandemic, there is still no easy or definitive answer to the question many retailers are asking about whether there is coverage for their business interruption losses related to COVID-19....more
10/14/2020
/ Agricultural Sector ,
Antitrust Violations ,
Business Interruption ,
Class Action ,
Commercial Insurance Policies ,
Coronavirus/COVID-19 ,
Dismissals ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
FSMA ,
Health Claims ,
NLRA ,
NLRB ,
Notice Requirements ,
OSHA ,
Putative Class Actions ,
Reversal ,
Tip Credit ,
Unfair Competition ,
Wage and Hour
Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more
In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...more
The widely reported shortages of Personal Protective Equipment (PPE), including masks and gowns, across the United States have led to the importation, distribution and use of PPE manufactured overseas. In particular, many...more
The U.S. Food and Drug Administration (FDA) has issued several final guidance documents to assist manufacturers developing medical products in response to the coronavirus (COVID-19) pandemic. While some are published as...more
The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more