New Drug Application , review

The New Drug Development Process Steps from Test Tube to New Drug Application Review, [Internet]. URL http //www.fda.gov/cder/handbook/ develop, htm, accessed 7-29-2000. 

The main activities of the PMDA are to offer the pharmaceutical industry consultations with regard to clinical trial protocols and drug and medical devices development plans, to conduct new drug application review and to confirm the quality of the submitted data. The PMDA, or Drug Agency, is composed of 15 offices to conduct different services (see Figure 35.3). 

The length of the period from submission of a new drug application to FDA approval was not estimated from the company survey rather, the authors estimated average new drug application review times from the CSDD NCE database. In the early study, Hansen used the reported mean time from NDA submission to approval of all approved NCEs in the database, 24 months. DiMasi used the reported mean NDA review time for approved self-originated NCEs first tested in humans between 1970 and 1982, 30.2 months. 

Figure 3. The New Drug Application review process chart describing the reviews and decision points leading to FDA approval...

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