2021 Global Conference on Regulatory Science October 12 - 13
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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.

Master Protocols and Adaptive Trial Designs to Develop Tumor – Agnostic Drugs for Children: Essential Tools in the Era of the Research to Accelerate Cure and Equity Act

Arfè, Andrea, Lewis B. Silverman, and Florence Bourgeois

Assessing the Filtration Efficiency and Regulatory Status of N95s and Nontraditional Filtering Face-Piece Respirators Available during the COVID-19 Pandemic

Plana, Deborah, Enze Tian, Avilash K. Cramer, et al. 2021

Remote Patient Monitoring – Overdue or Overused?

Mecklai, Keizra, Nicholas Smith, Ariel D. Stern et al. 2021

FDA Approval Standards for Anticancer Agents – Lessons from Two Recent Approvals in Breast Cancer

Gyawali, Bishal, and Aaron S. Kesselheim

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

Virtual Faculty-Student Mixer

September 22, 2021 12-1pm ET

RegSci Forum – COVID-19: Developing a Vaccine During a Pandemic

Dan Barouch | September 24, 2021 12-1pm ET

Virtual Webconference

Twitter @Harvardmit_CRS

Harvard-MIT Center for Regulatory ScienceFollow

Florence Bourgeois @ftbourgeois·

15 Sep

With just 10% of the NIH budget allocated to pediatric research, is funding supporting conditions with the greatest health burden in kids?

We analyzed >14K NIH grants to set a roadmap for ongoing assessment @JAMAPediatrics https://jamanetwork.com/journals/jamapediatrics/article-abstract/2783700 @Bos_CHIP @HarvardMIT_CRS

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

14 Sep

Register today for the next Regulatory Science Forum where Dr. Dan Barouch will speak about his outstanding work on the Johnson & Johnson Vaccine. https://bit.ly/3zgpAFO

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

9 Sep

Join us for an opportunity to remotely meet faculty, trainees, and students from Harvard, MIT, and other academic institutions who are interested in regulatory science. Advance registration is required: https://bit.ly/regscimixer21

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MIT Science Policy Review @SciPolRev·

6 Sep

Shejla Pollozi (@ShejlaPollozi), Cindy Xie, and Sumedha Sachar (@SumedhaSachar) talked with Florence Bourgeois (@ftbourgeois), Harvard Professor of Pediatrics, about policy and regulation of clinical trials. (6/7)

https://sciencepolicyreview.org/2021/08/florence-bourgeois-policy-regulation-clinical-trials/

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

1 Sep

Registration for the #RegSciGlobal conference is now open! RSVP and view the agenda here: https://bit.ly/3mWcfjd

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