The Food and Drug Law Blogs

18/01/2015

In recent months I have been studying for a degree in Quality Assurance and Regulatory Affairs in pharmaceutical drug development. While at first glance regulatory affairs may seem like a tedious and useless subject to study, especially for a basic research scientist involved in cutting edge academic research, it turns out that courses taught in the curriculum can be a perfect complement for any biomedical scientist wishing to pursue a career in industry.  Regulatory affairs in drug development is a science in and of itself, consisting comprising the study of various paths a drug manufacturer can/should navigate in order to develop a drug from preclinical testing to clinical trials to postmarket research.  All the while companies must coordinate with contract research organizations, institutional review boards, hospitals, health care providers, patients and of course the Food and Drug Administration. I am taking one of the core course modules this summer, which is Food and Drug Law. As part of the course I must write a weekly blog about an aspect of food and drug law that I find fascinating and make a presentation about the theme at the end of the semester. I have decided to focus my theme on drug law patents and the most current topics concerning that field. I thought it would be a good idea to simply post up my blog assignment onto my website for each week. So in the above blog entries, you will find essays concerning my reviews about drug patent laws as well as legal issues concerning the FDA.

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