Is Success Of US Market Applications Predictable?

A White Paper released by the Franklin Quest Consulting Group has dispelled the notion that the quality of US New Drug Applications can neither be measured nor their success be predicted. Until recently, the drug, biologics and medical device industries were not motivated to invest time and money needed to develop standards and processes for measuring the quality of marketing applications, according to the paper, Can You Predict the Success of Your Marketing Applications? delivered at a Regulatory Affairs Professionals Society conference.

Pharmaceutical Research and Manufacturers of America member companies will invest about $15.8 billion in R&D this year, it was noted. Submission documents which leave questions unanswered, or have unclear interpretations of results, delay the approval process, as well as jeopardize the success of R&D projects and the financial return needed to fund further development. The White Paper presented at the meeting outlines standards and processes developed by the company that can be used to predict marketing applications success.

Among the specifics it lists for high-quality applications are: - anticipating marketing, formulary and registration issues; - providing continual and consistent support for label claims or responses to issues about the adequacy and control of studies; - developing logical, comprehensive responses to issues; and - making responses to issues accessible to readers.