TransCelerate Research on Improving Clinical Trial Data Collection Published in DIA's Therapeutic Innovation & Regulatory Science

TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying clinical research, today announced the ...
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 ...
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 ...
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, ...
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 ...
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

Enhancing the Regulatory Science of Drug Development: A Workshop

The National Academies Forum on Drug Discovery, Development, and Translation convened this public workshop to examine the state of the science of drug regulation and consider approaches for enhancing ...
University of Manchester

Transatlantic MoU Revolutionises In-Silico Regulatory Science

A Memorandum of Understanding has been signed between UK CEiRSI (UK Centre of Excellence on In-Silico Regulatory Science and Innovation) and Triangle CERSI (Triangle Center of Excellence in Regulatory ...
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 ...