Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of regulatory science
is a discipline that creates new tools, standards, and approaches for use in assessing the safety, effectiveness, quality,
and performance of products.
In October 2010, FDA issued a framework for advancing regulatory science for public health, which focused on the following:
accelerating delivery of new medical treatments; improving pediatric and children's health; protecting against emerging infectious
diseases and terrorism; enhancing safety and health through informatics; protecting the food supply; modernizing safety testing;
meeting challenges for regulating tobacco; and setting a collaborative implementation framework.
Following that framework, in August 2011, the agency released a strategic plan for advancing regulatory science at FDA, largely
focused on science-based decision-making to improve public health. Part of this initiative identifies specific standards,
methods, and questions for drug reviewers to use in their review process. The overall effort builds upon the agency's Critical
Path Initiative, launched in 2004, to drive innovation in scientific processes, which includes the 2011 report that prioritized
eight areas, which included support for new approaches to improve product manufacturing and quality.
FDA has launched several Centers for Excellence in Regulatory Science and Innovation (CERSI) to carry out these priorities
(see sidebar on academia's role on page 28). The agency's initiative in regulatory science also was enhanced with the passage of the Food
and Drug Administration Safety and Innovation Act (FDASIA) in July 2012. Section 1124 of FDASIA calls for improving medical
product decisionmaking through guidance documents and the adoption of tools, methods, and processes. The US Health and Human
Services (HHS) Secretary must issue performance reports on these goals for fiscal years (FY) 2014 and 2016. BioPharm International spoke to FDA about these issues in a special interview on the future of bio/pharmaceutical regulation.
Academia’s role in the future of biopharma manufacturing and regulation, by Angie Drakulich