The increased use of data analytics for speedier clinical trials, more efficient regulation, and better population health management is at the top of the priorities list for the Food and Drug Administration (FDA) in the next four years, according to its latest FDA Strategic priorities report.  Analytics will be the foundation of several of the FDA’s ongoing initiatives, including reducing tobacco use, developing new methods of testing medical products and conducting clinical trials, and identifying health consequences of certain products or behaviors.“An increasingly global and complex marketplace, rapidly evolving technologies, and emerging areas of science are having a major impact on FDA’s mission to promote and protect the public health,” the report says. “FDA must tackle these new challenges expeditiously, as we continue to meet our core responsibilities. Working collaboratively with our international regulatory partners, we will continue efforts towards international harmonization and regulatory convergence. We achieve this by using smart regulatory approaches to streamline and modernize our regulatory programs and minimize regulatory uncertainty for industry, while protecting and maximizing public health and safety.”In order to accomplish its four core goals of oversight, access, informed decision-making and organization excellence, the FDA will rely on regulatory science, globalization, safety and quality, smart regulation, and financial stewardship.  At the heart of these strategies will be the use of analytics to inform standards for product development, distribution, and safety, as well as ways to detect consumer safety issues, risks, and adverse events.“FDA is already taking concrete steps to advance safety and quality across the Agency,” the report added.  “For example, the Case for Quality Initiative, which includes a voluntary compliance improvement program pilot, promotes medical device quality. The planned Office of Pharmaceutical Quality will highlight and consolidate quality principles and review throughout the drug lifecycle.”The Case for Quality Initiative will include a voluntary compliance improvement pilot program for medical devices, which “aims to reduce the risk of patient harm by helping manufacturers identify and deploy quality-related design and production practices,” the brief explains.  The Agency will also work to improve understanding of regulatory requirements and provide guidance to healthcare stakeholders and consumers through new rules and standards.“If biomedical science is to deliver on its promise, scientific creativity and effort must also focus on improving the medical product development process itself, with the explicit goal of robust development pathways that are efficient and predictable and result in products that are safe, effective, and available to patients,” the report concludes.

“Although FDA’s primary responsibility is to review the safety and effectiveness of new medical products developed by industry, the Agency is also committed to assisting product developers in translating discoveries in basic science into new therapies that will save lives and improve health care.”

Source: healthitanalytics.com