Last week, the FDA added new heart health risk information to mRNA vaccines’ fact sheets. In addition, the U.S. seized unauthorized COVID-19 drugs en route from Bangladesh and India to Mexico. ...more
Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s first guidance on remote interactive evaluations, a tool in response to the agency’s COVID-19 inspection postponements....more
Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and what manufacturers can do...more
The Food and Drug Administration released guidance for the use of convalescent plasma to treat COVID-19 to supplement its recently issued emergency use authorization. Our Food, Drug & Device/FDA Team analyzes the specifics of...more
Whether your products are used for medical purposes or used in homes and offices, our Food, Drug & Device/FDA and Environment, Land Use & Natural Resources teams highlight the key regulatory requirements that apply, what has...more
Government-enforced shutdowns and quarantines overseas have interrupted life-saving drug manufacturing, affecting the country’s ability to fight COVID-19. Our FDA Compliance & Enforcement Team reviews how the Food and Drug...more
The Food and Drug Administration (FDA) is racing to make coronavirus tests more widely available. Our Food, Drug & Device/FDA Team examines how the FDA is using its authority to issue emergency use authorizations (EUAs) to...more
Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s decision to temporarily postpone routine surveillance domestic inspections in the wake of the continuing coronavirus (COVID-19) outbreak....more
Our Food, Drug & Device/FDA Team discusses why the Food & Drug Administration is engaging with personal protective equipment (PPE) manufacturers and how it’s providing information to health care providers to mitigate...more
Our FDA Compliance & Enforcement Team examines the Food & Drug Administration’s decision to stop overseas inspections in the wake of the continuing coronavirus (COVID-19) outbreak....more
Our Food, Drug & Device/FDA Group breaks down the new Food and Drug Administration guidance on data integrity for current good manufacturing practices (CGMPs) and what it means for the drug industry....more