The Food and Drug Administration (FDA) is amending its combination product regulations to define “mode of action” (MOA) and “primary mode of action” (PMOA).
Where,
MOA is the means by which a therapeutic product achieves an intended effect or action.
and PMOA is the single mode of action of a combination product that provides the most importa…[Read more]

I took Dr Collins class “Biomaterials” last spring, and this discussion took me back to a discussion we had in class about the Global Regulatory Environment.
The FDA has very stringent rules, that they are adamant into applying. Whereas other countries in the world do not have such strict guidelines for drug/medical device distributions. So…[Read more]

In my opinion the Fitbit should be classified as a Class 1 device as similar device exist in the market. This will help decrease the testing period as their are similar devices that prove that such devices are safe and of low risk.

Ashley, I checked the FDA website to answer your question, and it turns out that the Fitbit has surprisingly been…[Read more]

During my internship in the Saad Research and Development center, I worked in a Matrix based industry. There were two organizations locally and two internationally that were funding the research that were going on in the center.
From this experience I assessed that I would personally like to work in a Project based industry for a year or two to…[Read more]

I agree with the baseline points that everyone has made that a good team compromises of individuals with good communication, are hard working and have a knowledge of the problem. These are some qualities that you would find in any good project team. As a project manager a common trait that I would look in all of my team members is…[Read more]

As much as I agree with everyone about the importance of technical skills, it’s important to note that employers prefer to train people they bring into work so that they are able to deliver what’s expected of them perfectly and meets the demand of the company.
Having a base technical background is important to pave a path into acquiring a…[Read more]