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Background Approval of regulated medical products in the USA is based upon a rigorous review of the benefits and risks as performed by the US Food and Drug Administration (FDA) staff of scientists and is summarized in a descriptive and qualitative format called the FDA’s Benefit–Risk Framework (BRF). This present method highlights the key factors in regulatory decision-making, but does not clearly define the reason for its final approval. Method This study proposes a quantitative version of FDA’s BRF to calculate a Net-Benefit Score and a Benefit–Risk Ratio as a method to define a single-value summary of the tradeoffs between benefits and risks and allow comparisons among other products. In this retrospective review of five years of new molecular entities and new biologic (N = 185 products) regulatory decision-making, this proposed scoring system codifies and quantitates the information about a product’s benefits, risks, and risk management information in a format that may predict why regulated medical products are approved in the USA. Results Simple calculation of codified benefits, risks, and risk mitigations with numerical limits is proposed to provide a repeatable process and transparency for documenting the net-benefit of regulatory product approval. Conclusion Use of a strict process of collecting, codifying, and analyzing public information to determine a Net-Benefit score and a Benefit–Risk Ratio is possible to anticipate regulatory product approval.

The premise of this paper is a concern over the dismal record of approvals for biotechnology products despite the enormous resources poured into their development. The authors have described a number of issues which may help to explain the dearth of biotechnology product approvals. Included among those issues are suggestions for improving the development process by ensuring the presence of several key resources which may be overlooked by emerging biotechnology companies. Particularly, the authors advocate creative approaches to development rather than relying too strongly on approaches used in the past. As well, the authors suggest that applicants should intelligently use the resources of the Food and Drug Administration (FDA) for guidance and input into the development process. Finally, the authors suggest that when both applicants and FDA work smarter and faster, there will be many more approvals of biotechnology products.