By Richard A. Guarino and Richard Guarino
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If the product is not shown to produce subject benefit, the entire program may be lost. CONSIDERATIONS FOR PATIENT BENEFIT OF A PRODUCT Patient benefit is r r r r sometimes quite arbitrary, often difficult to define, difficult to gain FDA agreement and concurrence with, and often difficult to achieve once agreed upon. While planning clinical trials it is important to know the potential benefits of your product and conceptualize what actual subject response may be demonstrated. When it is determined that subject response to treatment may actually be a clear demonstration of subject benefit, there is a good probability that product will meet FDA requirements for efficacy approval.
INTRODUCTION Over the years, representatives of both the regulatory agencies and the pharmaceutical industry have published in pharmaceutical journals or presented at workshops many helpful suggestions to facilitate regulatory review of the Common Technical Document (CTD) or other submissions and to avoid elements that impede the review. Several authors and presenters have expressed reviewers’ frustration at having to review a submission that is incoherently assembled or confusing in its presentation.
This redundancy adds considerably to the length of the sentence, and the burden on the reviewer is further compounded if multiple ranges are compared within one sentence. Consider dispensing with this nicety to improve flow and comprehension. Data Presentation for Global Submissions 25 Correctness The textual presentation should agree with the tabular data in each section of the Common Technical Document or other global submissions; in turn, the tabular data should agree with the data source (which agrees with the case report form and other clinical documentation).