What Does the End of the COVID Public Health Emergency Mean for Emergency Use Authorizations?

What Does the End of the COVID Public Health Emergency Mean for Emergency Use Authorizations? February 27, 2023 I remember listening to many predictions after the Department of Health and Human Services (HHS) issued the COVID-19 public health emergency Jan. 31, 2020. None of them included that it would last for more than three years! […]

What is the Product’s Intended Use?…a Simple Question With a Big Impact on the Success of Your Regulatory Strategy

What is the Product’s Intended Use?…a Simple Question With a Big Impact on the Success of Your Regulatory Strategy February 27, 2023 You’ve no doubt heard the old adage, “measure twice and cut once.” It applies to many things, including the creation of a regulatory strategy. After 35 years in the industry, including teaching regulatory […]