Prescription drugs marketing applications

Pathak, D.S. Kucukarslan, S.N. Segal, R. Explaining patient satisfaction/dissatisfaction in the high blood pressure prescription drug market An application of equity theory and disconfirmation paradigm. J. Consum. Satisfac., Dissatisfac., Complain. Behav. 1994, 7, 53-73. 

A great majority of botanical sponsors have taken advantage of the pre-IND consultation service provided by FDA. As a result, most IND applications were successful with initial submission and few (less than 20) were placed on clinical hold for safety concerns. However, despite the early success, many development programs and research projects have subsequently been suspended for various reasons. As of the above-mentioned cutoff date (April 30, 2004), nearly two-thirds (66%) of INDs still remain active (have not been placed on clinical hold, inactivated by FDA, or withdrawn by sponsor for lack of activities). To date, there have been no submissions of NDAs to FDA for marketing approval of botanical prescription drugs. 

Other laws impact FDA s operations. For example. The Food and Drug Administration Modernization Act of 1997 and Prescription Drug User Fee Act Amendments of 2002 give authority to FDA to collect user fees for review of certain marketing applications. They also set performance goals for the Agency to meet review timelines (http //WWW. fda.gov/cder/pdufa/). 

In the mid to later part of the 1990s, procedures were established to allow for more timely review and approval of marketing applications in the both European Union and the United States. The review process to be used and the timing for approval are defined by the local regulations, and are dependent upon the immediate therapeutic need for the product. The EU mutual recognition and centralized procedures and the U.S. Prescription Drug User Fee Act (PDUFA) will be discussed in more detail later in this chapter. 

CFR Title 21, 314—Applications for FDA approval to market a new drug (FDA, 2003b) Labeling for human prescription drug and biological products— implementing the new content and format requirements (FDA, 2006b)... 

New drugs will only be authorised as prescription medicines in the first instance, as it requires considerable experience in the market to convince the regulators that it is safe to reclassify a drug as an OTC product. The term new drug may mean a new pharmaceutical substance, or a new therapeutic application of an existing one. 

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