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The Focus is on Timely Product Approval Needless to say, to many small clinical-stage companies, limited resource is a common disadvantage. However, it can be turned into its advantage if the company chooses the right registration target [i.e., 505(b), 505(b)(2), or 505(j)], appropriate clinical development package, and appropriate resource allocation, with the intention to put a product into market through the shortest path. Besides financial investments, there are three key factors, as illustrated in the table below, that contribute to a successful NDA approval within a given time period:
More importantly, the importance of each of these factors changes as a product moves along its development stages, from pre-clinical to clinical and to registration! Depending upon the target selected, the Management’s task is to facilitate this process and make sure that the appropriate resources are allocated to each of these areas at various stages, and deliverables are delivered on time and meet specifications.
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