RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS

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 …›

FDA’s Covid-19 Product Regulation Enforcement Roadmap

Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA …›

First Decisions Limit PREP Act Immunity in Coronavirus Context

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act …›

COVID-19 Alert: FDA updates antibody test policy

Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been …›

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19. The PREP Act grants tort liability …›