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These applications have become so massive that the FDA now allows sponsors to le them in electronic form The time taken by the agency to review new drugs increased year by year, both because of an increase in the number of applications and the data that were required Legislation passed in 1992 imposed a review fee on sponsors Proceeds are intended speci cally to allow the agency to add staff so as to expedite the process Review times have shortened signi cantly since then Legislation in 1997 allowed the FDA to designate selected drugs as important therapeutic advances Those agents then receive formal Fast Track Review Whatever the track, the months after ling will be a busy period for the sponsor in answering inevitable questions from the FDA reviewers.

When all questions have been satisfactorily addressed, the agency will present the data on the new drug to its Advisory Committee in the relevant therapeutic area This group of outside experts will then consider the data at an open public meeting and vote on whether the drug should be approved or whether they consider more data are needed The FDA almost, but not invariably, follow the Committee recommendation Receipt of an approvable letter from the FDA often comprises the nal step in this long process This letter not infrequently requests some changes in the labeling or in the package insert This last document is hardly read by anyone and is routinely removed from packages by the pharmacist It actually consists of a relatively concise summary of the NDA, whose wording is negotiated between the sponsor and the agency.

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A very large number of important new drugs in various therapeutic classes were introduced in clinical practice in the early to mid-1960s These entities became an.

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C.7.2 Using Server Stubs to Test Client Functionality Deploying the Server Stub as Part of the Nightly Deployment Process Server stubs should be used to assist in creating and testing the client. Server stubs act as endpoints to which clients can send SOAP requests and from which clients can receive SOAP responses. It is important to test the client not only against the server that is being developed but also against a stub, because otherwise when a problem is encountered, it will not be known whether the problem is due to a defect in the server or due to a defect in the client. Server stubs should be able to return expected SOAP responses as well as intentionally bad SOAP responses. They should time out at the HTTP level and also refuse connections. For example, a server stub could simply return a string inside the SOAP body back to the client using a Python script. The script and the server stub can be modi ed to return various SOAP responses. In this way, the client can be tested against various SOAP responses. Additionally, the server stub can be con gured to process the SOAP requests as needed.

Potential Obstacles There are three potential hurdles to overcome in Step Four. As discussed earlier in this chapter, the inf lux of data and the information generated by automated agents could cause corporate executives to oversteer their organizations. It is important that they keep in mind the larger trends and avoid overreacting to the immediacy and wealth of information available to them. Second, pervasive technology has great potential. However, depending on its use, software such as agents could become an annoyance for consumers and in some cases an invasion of privacy. By monitoring personal preferences and tracking consumption and spending habits, agent technology walks a fine line between help and hindrance. To make this software beneficial, companies must be careful to never use agents in a way that is invasive or that enables them to become a nuisance. Consumers must be allowed to retain control, so they can turn the software off. Finally, companies setting out to complete Step Four can easily become technically overloaded by the overwhelming amount of data as well as culturally overloaded by the amount of change involved. It s important that companies understand their goals before embarking on this effort, and develop an achievable road map for success that enables them to absorb these changes at a pace they can handle.

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