Harvard-MIT Center for Regulatory Science

Harvard, MIT, and the FDA have partnered to create a center focused on regulatory science, bringing together a range of scientific disciplines that are applied to assess the quality, safety and efficacy of medicinal products and inform regulatory decision-making throughout the lifecycle of a medicine. Working across academia, industry, and government institutions, the Center promotes regulatory science through research and education programs, uniting stakeholders under a common mission: promoting optimal patient health outcomes through biomedical innovation and the availability of safe and effective diagnostics and treatments.

The Harvard-MIT Center for Regulatory Science was formally launched in 2018 to advance research and education in regulatory science. The Center serves the broad community of biomedical research scientists and physicians in academia, industry, and regulatory agencies who seek to improve the development and evaluation of medical products. The Center is open to faculty and trainees from all institutions in the Boston area and aims to establish a three-way dialogue between academic medical research, drug development in biotechnology and pharmaceutical companies, and clinical care in the US and worldwide.

The Center supports a Regulatory Science Fellowship, local and international conferences, and a portfolio of research collaborations with regulatory agencies, industry, and other academic institutions.

The Center supports researchers conducting projects in regulatory science and facilitate cross-disciplinary collaborations between academic groups, biotechnology and pharmaceutical companies, and regulatory agencies.

Harvard, MIT, and the FDA have partnered to create a center focused on innovative approaches for the development and evaluation of medical products. Together, we engage with partners in regional academic institutions, biotechnology and pharmaceutical companies, regulatory agencies, patient advocacy groups and other nonprofit organizations.