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Category: FDA

Data Driven: Mining ClinicalTrials.gov – Institutions, Funding, and Areas of Focus

  This is Data Driven, a new series that explore our nation’s health agencies’ publicly available data. This data, which is comprised of searchable online databases and files, presents a unique opportunity to analyze information on broad health care topics. We thought it would be interesting to explore data from agencies whose work most closely…

Stakeholder Connect | Four Years Later, Breakthrough Continues to Exceed Expectations

In 2012, the Breakthrough Therapy Designation was signed into law. Four years later, Friends of Cancer Research (Friends) continues to steward the program that the organization developed by working closely with FDA and other stakeholders to ensure the program is as efficient and effective as possible. As part of this stewardship, Friends hosted a Senate briefing…

Stakeholder Connect | Katie Couric, Mark McClellan, and Ellen Sigal Huffington Post Op-Ed on 21st Century Cures

Congress Must Pass 21st Century Cures Act Now This is an incredibly exciting time in biomedical research. New discoveries are announced almost every week that bring us closer to managing cancer and other life-threatening diseases. We are attacking these illnesses at the molecular and genetic levels. In cancer, for example, scientists have gone beyond treating…

Stakeholder Connect | In Case You Missed It: Highlights from March, April, May & June 2015

It’s been a busy spring for drug development. We’ve had leadership changes at FDA, legislative pushes in Congress, and a host of conferences and meetings to present and advance ideas from the cutting edge of science and policy. It’s a lot of keep up with. Here are the biggest stories from the last few months.…

Stakeholder Connect | 21st Century Cures is Moving Quickly Through the Legislative Process – Here’s What You Should Know

This Friday, the U.S. House will vote on the 21st Century Cures Act. The Act creates a cohesive, efficient, effective, and patient-centered path to cures. The 21st Century Cures Act, a substantial piece of legislation that touches on all aspects of medical innovation – from basic research to regulation, from biomarkers to patient data –…

Stakeholder Connect | A Conversation with FDA Commissioner Dr. Margaret Hamburg (Part 2)

Margaret Hamburg has been the Commissioner of the Food and Drug Administration (FDA) since 2009. In the below entry, part 2 of 2, Dr. Hamburg discusses her experience as Commissioner, her perspective on the FDA, and her advice for future FDA Commissioners. The interview was conducted by Ryan Hohman, Managing Director, Policy & Public Affairs of Friends…

Stakeholder Connect | A Conversation with FDA Commissioner Dr. Margaret Hamburg (Part 1)

Margaret Hamburg has been the Commissioner of the Food and Drug Administration (FDA) since 2009. In the below entry, part 1 of 2, Dr. Hamburg discusses critical issues in FDA drug policy, including the use of surrogate endpoints and the development of new regulatory tools. The interview was conducted by Ryan Hohman, Managing Director, Policy & Public…

What leaders in the field are saying about Lung-MAP

A unique public-private collaboration among the National Cancer Institute (NCI), part of the National Institutes of Health, SWOG Cancer Research, Friends of Cancer Research (Friends), the Foundation for the National Institutes of Health (FNIH), the US Food and Drug Administration (FDA), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune),…