Title: Abgenix

Essay Details

Subject: Technology
Author: Louise E
Date: August 12, 2014
Level: University
Grade: A
Length: 10 / 2787
No of views: 0
Essay rating: good 0, average 0, bad 0 (total score: 0)

Essay text:

After demonstrating the safety and efficacy of the drug through successful clinical trials, the sponsor company submit that information, along with information on manufacturing specifications, drug stability and bioavailability, and suggested packaging and labeling, as a "new drug application" (NDA) to the FDA...

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The NDA is then reviewed by teams of FDA employees, including physicians, statisticians, chemists, pharmacologists, and other scientists who assess the validity of the sponsor's claims. FDA inspectors also examine the facilities in which the sponsor intends to manufacture the drug The outcome of such process could be "approved", "approvable" (meaning adjustments have to be made), or "not approved"...

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