1) What are the pros and cons of Abgenix\'s collaborating with a partner on ABX-EGF?
Before a new drug can be released to the market, it has to undergo a regulatory process. To complete the process, first the drug company (the sponsor in the process) has to submit information to prove that the drug is safe and effective. Pre-clinical data first has to be submitted before clinical trials can be conducted. 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. 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......
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