CRS fellowship opportunity in Pediatric Real-World Evidence research
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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.

US Food and Drug Administration Approval of High-Risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021

Wunnava, Susmitha, Timothy A. Miller, Claire Narang, et al. 2022

Regulatory Considerations to Keep Pace with Innovation in Digital Health Products

Torous, John, Ariel D. Stern, and Florence T. Bourgeois, 2022

Risks to the 340B Drug Pricing Program Related to Manufacturer Restrictions on Drug Availability

Knox, Ryan P., Aaron S. Kesselheim, and Ameet Sarpatwari, 2022

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 “Fellows Showcase”

CRS Fellows | February 7, 2023 12 – 1pm ET

Virtual Webconference

Innovators in Therapeutics Speaker Series

Dr. Adam Rogers, Interim President, NerveGen Pharma | February 15, 2023 12 pm ET

Twitter @Harvardmit_CRS

Harvard-MIT Center for Regulatory ScienceFollow

Center within @HiTSatHarvard @HarvardMed • Drug development, translational science & @US_FDA #FDAInformed

Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

18 Jan

Please join us for a special edition of the #Regsci forum, featuring lightning talks from CRS Fellows. This is a great opportunity to learn about their amazing research! RSVP http://bit.ly/3ZYDBqf

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

9 Jan

Exciting publication from @HarvardMIT_CRS fellow @ryanpknox on a very relevant topic #patent #antitrust #competition #Pharmaceutical

Nature Biotechnology@NatureBiotech

The Humira patent thicket, the Noerr–Pennington doctrine and antitrust’s patent problem https://go.nature.com/3uS9lPa

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

5 Jan

Register for the first #RegSciForum of the year! Delighted to host the FDA speakers Jill Marion & Mary Beth Ritchey @FDADeviceInfo #RWE #MedDevice #clinicalevidence https://harvard.zoom.us/meeting/register/tJModOGprj8pH9LNiePeWZeQylp-Zo-oZ2ze

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

6 Dec

At the last #RegSciForum of 2022, we were joined by Dr. Caleb Alexander, who led a lively discussion on "Regulatory Flexibility in the 21st Century." Thank you to everyone who logged in!

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

1 Dec

The latest CRS newsletter is available here. ➡️ http://bit.ly/3H2boYv Subscribe so you don't miss future editions! 🔗https://bit.ly/crsnewsletter

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