by Dr. Yashashwini Reddy | Jun 25, 2024
While learning regulatory affairs there are several abbreviations you come across, you usually end up searching for them. Here is a list of abbreviations that are commonly repeated. There are several topics related to regulatory affairs where you come across these...
by Dr. Yashashwini Reddy | Jun 15, 2024
Navigating the Premarket Notification (510(k)) Process Premarket notification is a regulatory pathway for getting the FDA’s clearance of medical device marketing in the US. A 510(k) is a premarket submission made to the FDA to provide evidence that the medical...
by Dr. Yashashwini Reddy | Jun 3, 2024
Life Cycle Management of Investigational New Drug Application: Life cycle management of IND applications involves activities that ensure compliance with the regulatory requirements and the safe & smooth running of clinical trials. The important things to consider...
by Dr. Yashashwini Reddy | Jun 3, 2024
What is an Investigational New Drug (IND) Application and When is it Required?” In this article you are going to learn about IND and its types and when an IND is required. Generally, in the US to conduct clinical trials i.e. for the administration of...
