Deborah Shelton

This week, FDA published a draft guidance on the use of registries to support regulatory decision-making. In this guidance, titled "Real-World Data: Assessing Registries to Support Regulatory Decision-Making or Drug and...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