On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a...more
As critical product shortages arose during the early days of the COVID-19 pandemic, the Food and Drug Administration (FDA) issued guidance documents outlining temporary policies that allowed non-drug manufacturers to produce...more
Hospitals have long used color-coded wristbands as a patient safety initiative. Recently, the FDA issued a letter to medical device manufacturers to caution them against using colors for device identification wristbands that...more
With the FDA’s emergency use authorization (EUA) and now widespread availability of multiple COVID-19 vaccines in the United States, an increasing number of public and private entities are considering requiring or have...more