Regulatory Compliance Consultant Tag

A recall can make all consumers especially nervous, but for a company issuing such an action, this can be evermore daunting, though it doesn’t need to be. A recall is essentially a removal of a product from the market for a...

President Donald Trump, in his first few weeks in office, has been forging ahead with executive orders, making good on promises made while campaigning. He has signed one such executive order (EO), “Reducing Regulation and Controlling Regulatory Costs”(1), which intends...

In 2007, several high-profile drug safety problems triggered Congress to mandate the FDA to develop an active surveillance system, utilizing electronic health data, to improve tracking and analysis of drug safety after drugs reach the market [1]. During the drug...

Since its creation in 2002, the Office of Combination Products (OCP) has been tasked with developing regulations and guidance documents for combination products [1]. A combination product is a product composed of any combination of drug/device, drug/biologic, biologic/device, or device/drug/biologic...