Conference Proceedings and videos for the 2020 Global Conference on Regulatory Science are now up!
READ THE REPORT NOW
Improving the Process of Therapeutic Development
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.
Featured Publications
The Regulatory Science Fellowship Program
Our fellowship program is affiliated with the FDA and focuses on training the next generation of regulatory science researchers. Learn more about the research our fellows are conducting or explore opportunities and how to get involved in our program.
News, Events, & Updates
RegSci Forum: Benefit-Risk Analysis of Regulatory Decision-Making
GK Raju | May 11, 2021 12-1pm ET
Virtual Webconference
Twitter @Harvardmit_CRS
Assessing the filtration efficiency and regulatory status of N95s and nontraditional filtering face-piece respirators available during the COVID-19 pandemic https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06008-8 via @PanFabBoston @BioMedCentral
NEW in @STATnews with @StephenLatham @YaleBioethics:
Patient advocacy organizations and FDA drug approval: lessons from Aduhelm
https://www.statnews.com/2021/07/23/patient-advocacy-organizations-lessons-from-aducanumab/ #Aduhelm #aducanumab #patientadvocacy #patientadvocate #patientsoverprofits
'Current private incentives have not solved public health needs, but has led to the approval of many antibiotics that lack of evidence of added value. More up-front government investment may be a better strategy' from @DrSinhaEsq et al https://academic.oup.com/jid/article-abstract/223/9/1506/5896002#.YOxzQb0qgME.twitter
This fall, I'll be starting as a postdoc at @HarvardMIT_CRS! I'm really excited to work with people that I've cited for years and do research that can improve how we regulate medical devices and drugs.