The Research to Accelerate Cures and Equity for Children (RACE) Act will close loopholes in U.S. drug approval guidelines that companies have exploited to avoid enrolling children in clinical cancer research. more→
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Expanded access programs: Making compassion work (Regulatory Focus)
KVC’s Program Director outlines challenges and necessary next steps in improving access to compassionate use drugs. more→
Why can’t dying patients get the drugs they want? (The New York Times)
Right to Try legislation “is not going to fix the problem because there are still a lot of reasons why the companies will choose not to share their drugs,” says Nancy Goodman. more→
This week in pediatric oncology – Interview with Nancy Goodman (audio)
Dr. Timothy Cripe from Nationwide Children’s Hospital talks with Nancy Goodman, Founder and Executive Director of Kids v. Cancer, about accomplishments and her hopes for the future. more→
Pediatric cancer studies: FDA promises flexible approach on requirements (The Pink Sheet)
FDA plans a flexible approach to the new pediatric study requirements for targeted drugs under the RACE for Children Act. more→
Eyes on immunotherapy: Nancy Goodman speaks at the Atlantic Forum Children & Cancer
A video on how Kids v Cancer is creating incentives and requirements for companies to undertake pediatric studies. more→
How to try an experimental drug when you don’t qualify for a clinical trial (Forbes)
How to handle compassionate use requests is not taught in medical school. In essence, the process has four steps. more→
To speed access to compassionate use, look beyond the FDA (Health Affairs Blog)
Contrary to widespread industry concerns that serious adverse events in a compassionate use program will lead to problems with the FDA, analysis of years of data does not show this to be the case. more→
Senate passes pediatric cancer drug development expansion bill (Health IT Analytics)
A bill that would expand the number of pediatric cancer drug treatments for development passed the US Senate and heads to the White House for signing. more→
Senate passes ‘right to try’ bill to help terminally ill patients get experimental drugs (Washington Post)
The Senate on August 3 passed a measure designed to make it easier for terminally ill patients to get access to experimental treatments without oversight from the FDA. more→
Senate passes F.D.A. funding and ‘Right to Try’ drug bills (New York Times)
The FDA bill includes new requirements that could increase the number of cancer drugs for children. more→
Van Hollen bill to advance treatments for childhood cancer passes Senate
U.S. Senators Chris Van Hollen (D-MD), Michael Bennet (D-CO), Marco Rubio (R-FL), and Cory Gardner (R-CO) today applauded the passage in the U.S. Senate of the RACE for Children Act as part of the FDA User Fees reauthorization bill. more→
Act could aid childhood cancer fight (Tahlequah Daily Press)
As part of the FDA Reauthorization Act of 2017, the Research to Accelerate Cures and Equity (RACE) for Children Act passed unanimously through the House. more→
Leveraging FDA resources to encourage students to pursue STEM careers (FDA Voice)
Richard Pazdur, Director of the FDA Oncology Center of Excellence, introduces the pilot Summer Scholars Program, designed to introduce students to oncology drug development. more→
Colorado’s Bennet, Gardner applaud House passage of RACE for Children Act (Valley Courier)
Today’s passage of the RACE for Children Act in the House is a significant step for children around the country who deserve lifesaving treatments. more→