RACE Act Increased the Number of Cancer Drugs with Required ...

RACE for Children Act Spurs Pharma to Study Molecularly Informed ...

... legislation is prompting drugmakers to study more molecularly informed drugs in pediatric cancer trials. Based on the success of RACE, which ...

Here's What Sponsors Need to Know About the Race for Children Act

The difficulty in pediatric oncology drug development is attributed to a combination of factors. Many pediatric cancers are rare and development strategies are ...

Pediatric Cancer Drug Development - Charles River Laboratories

To increase pediatric cancer drug development, the Research to Accelerate Cures and Equity (RACE) Act for Children requires all oncology therapies to be ...

5 Things to Know About the FDA RACE for Children Act

The Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients.

Bipartisan Legislation Would Expand Childhood Cancer Drug ...

“By ensuring adult cancer drugs with the same molecular targets as pediatric cancers are subject to PREA requirements, the RACE Act will ...

AACR Annual Meeting 2023: The Past, Present, and Future of ...

In 2020, the U.S. Food and Drug Administration (FDA) instituted the Research to Accelerate Cures and Equity (RACE) for Children Act, which ...

RACE for Children Act Could Substantially Increase Studies of ...

The Research to Accelerate Cures and Equity (RACE) for Children Act has the potential to substantially increase the number of required pediatric studies for ...

The Impact of the RACE for Children Act | Cancer Today

Legislation to speed cancer drug development for ... number of oncology drugs that are required to be tested in kids and adolescents.

FDARA's Impact on Pediatric Cancer Drugs: Insights From May 2024 ...

The subcommittee evaluated the implementation of FDARA and how this law affects the need to study certain targeted cancer drugs in children.

More Drugs Tested in Pediatric Cancer: RACE for Children Act

The legislation was passed by Congress in 2017 and took effect in August 2020. It requires that therapeutics that are approved for adult cancers ...

RACE Act (BPCA/PREA) — Now at childrenscancercause.org

The Senate overwhelmingly passed the Research to Accelerate Cures and Equity for Children Act - known as the RACE Act - on August 3, 2017.

H.R.1231 - 115th Congress (2017-2018): RACE for Children Act

The bill limits waivers of pediatric assessments for medications that target a molecule germane to a pediatric cancer for which there is a need for additional ...

More Pediatric Cancer Trials Conducted Due To RACE Act - Citeline

Initial data looks promising as the FDA's pediatric oncology subcommittee is set to discuss how recent legislative changes have impacted ...

RACE Act Implementation: Our Comments on Draft Guidance

The 2017 passage of FDARA included provisions from the Research to Accelerate Cures and Equity for Children (RACE) Act, which improved ...

How the RACE for Children Act will get drugs to kids with cancer

Moreover, PREA requirements for cancer drugs are almost always waived because pediatric cancers are orphan diseases. The RACE for Children Act ...

Abstract 1023: Evaluating the impact of the RACE act - AACR Journals

Prior to the RACE Act, pediatric studies were waived for orphan drugs, regardless of possible applicability of the agent to pediatric cancers.

Catalyst for Improved Pediatric Cancer Treatments | PPD Inc

The RACE Act shifts the development focus from indications to molecular targets and supersedes previous exemptions. As such, it requires ...

A decade of FDA approvals for pediatric cancer indications

Cancer drug approvals with PMRs under the RACE Act ... A disproportionate number of expanded access requests for cancer drugs are for pediatric ...

New legislation to promote paediatric studies for new cancer ...

Under the Research to Accelerate Cures and Equity for Children (RACE) Act, the US Food and Drug Administration (FDA) was, from August, 2020, authorised to ...

The RACE Act and Pediatric Trials of Adult Cancer Drugs

In 2017, Congress passed the Research to Accelerate Cures and Equity (RACE) for Children Act to expand mandatory pediatric testing to cancer drugs; the law took ...