FDA 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...

In Back to Basics: Complaint Handling – Part I the basic requirements for complaint handling were discussed and we left off at the topic of MDRs. From a high level, a MDR is a post-market surveillance activity required by the FDA to...

In today’s fast paced society, innovation and progress are the name of the game, especially in the medical device industry. However, placing so much pressure on the development of new technology puts resolving issues associated with products, already on the...