Hi! my name is Carlos... I'm part of UF's First Innovation Academy. I'm a chemistry major with aspirations of becoming a United States Pharmacist. As a youth I was raised in Nassau up to age eight, after which I moved to Fort Lauderdale and spent the rest of my life there. My interests at the moment include but are not limited to preparing myself for occupational success and my personal fitness.
Call number ranges:
LCCN 89-456/-KF26 .L27 2005q - FDA's drug approval process after a sponsor demonstrates that their benefits outweigh their risks for a specific population and use
R856.6 .H45 1993-RA399.A3 P82 2011 Regulating medical devices
S. hrg. ; 109-850: future of drug safety
I was really pleased with the google workshop. One of the most important things I got out of it was how to use boolean search terms to refine my google searches. I learned about Boolean search in a previous class lecture, but the google workshop really gave me a better understanding of how to use it. The multiple search examples really were useful.
book-Guarino, R. A. (1993). New drug approval process. New York: M. Dekker.
journal-Worsnop, R. L. (1997, June 6). Reforming the FDA. CQ Researcher, 7, 481-504. Retrieved from http://library.cqpress.com/cqresearcher/
-FDA(2013, Jan 03). How Drugs Are Developed And Approved. www.fda.gov. April 13, 2013, retrieved from http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/
--Reforming the FDA is an online article available via CQresearcher that gives a critique on the FDA's drug approval process. The author of this article Richard L. Worsnop proposes the question "Does the agency act too slowly?" This is caused by recent problems in public management of drug that are regulated by the FDA. The reason that this author felt it was important to discuss this issue is because he researched that 25 percent of consumer income is used towards products that are regulated by the FDA. This article is very relevant to research on the FDA drug approval process because it gives an opposing viewpoint on the process from someone who can be considered to be creditable. Richards has written many other scholarly works and has a high public reputation.
--FDA's "How drug are developed and approved" is most likely the best article to read for learning about the Drug process in the United States since it comes directly from the organization that is responsible for Drug approval and regulation. The only downfall to this online writing is that since it is written by the FDA themselves you will only hear their side of the story. Anything that others may view unfair about this process and opposing points of views will not be likely to be seen. The main purpose of this article was to describe the drug approval process Briefly and give and overview of how it all works. This is a very complicated process with a lot of rules and regulations so its not really useful for gaining an intimate understanding of the drug approval process, but it is useful for those with little knowledge about drug regulation who want to gain insight without being too overwhelmed.
--In New Drug approval process, Richard A. Guarino extensively details that process in the development of new drug. This book is really helpful for gaining an understanding of the drug approval process in the United States since it goes into so many details about the requirements, the actual process of drug development, and factors affecting drug development. Besides pharmaceutical drug development Richard details the approval of biological (any substance, as a serum or vaccine, derived from animal products or other biological sources and used to treat or prevent disease) and medical devices. Richard’s himself is a very creditable author; this book has received reviews from many important organizations such as The Journal of Medicinal Chemistry. Basis is not something that needs to be worried about too much in this novel since it’s just a book that details the requirements for drug approval in the United States.
The Drug approval process in the United states.