Nature

Regulatory science: Researchers in the pipeline

Prospects are starting to look bright in the growing field of science intended to aid regulation of food safety and drug development. When the Deepwater Horizon rig exploded in April 2010, releasing ...
Technical

UMSOM student competition winners score the chance to work on regulatory science with FDA

For more than a decade, students at both the University of Maryland, Baltimore and the University of Maryland, College Park have used the America’s Got Regulatory Science competition to develop tools, ...
National Academies of Sciences%2c Engineering%2c and Medicine

Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: A Workshop

The Food and Drug Administration (FDA) defines regulatory science as the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, toxicity, public ...
STAT

FDA is smashing the status quo for regulatory science

A recent press release from the Food and Drug Administration titled “Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of ...
UC San Francisco

FDA Funds UCSF-Stanford Center on Regulatory Science

The U.S. Food and Drug Administration has awarded the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) a five-year grant with up to $25 million in funding.
PharmTech

FDA Reports on Advancing Regulatory Science

The US Food and Drug Administration has released an implementation report on its Regulatory Science Initiative. The report outlines the agency's plans to advance regulatory science through new tools, ...
MD&M East

FDA Adds New Regulatory Science Tools for Assessing Medical Devices

FDA recently added five tools to its catalog of regulatory science tools to help assess medical devices, including phantoms and laboratory methods. Here is a brief description of each new tool, along ...
National Academies of Sciences%2c Engineering%2c and Medicine

Advancing Regulatory Science for Medical Countermeasure Development - A Workshop

The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide expert advice on some of the most pressing challenges facing the nation and world. Our ...
Foreign Policy

Op-ed: PMDA advances regulatory science-based “rational medicine”

This issue is preventing our website from loading properly. Please review the following troubleshooting tips or contact us at [email protected]. By submitting your ...
PharmTech

Can EMA’s Regulatory Science Strategy Meet Medicine’s Major Challenges?

EMA’s strategy for regulatory science has divided opinion amongst various industry bodies. Editor’s Note: This article was published in Pharmaceutical Technology Europe’s May 2020 print issue. The ...
Nature

Efficient drug approval and monitoring must rely on sound regulatory science

The path to drug approval is long, hard and often perplexing. In recent months, the US Food and Drug Administration (FDA) has promised to bolster 'regulatory science', which aims to transform its ...