home > ict > winter 2020 > race for children act: product development considerations
International Clinical Trials

RACE for Children Act: Product Development Considerations

In August 2020, the RACE for Children Act will go into effect. Until now, certain treatments, such as cancer drugs with orphan designation, were exempt under the Pediatric Research Equity Act (PREA). The RACE for Children Act eliminates the orphan exemption for new cancer drugs directed at molecular targets relevant to children’s cancers.

Complying with the RACE for Children Act and PREA

With the RACE for Children Act, any original new drug application (NDA) or biologics licence application (BLA) submitted on or after 18 August 2020, for a new active ingredient to treat an adult cancer indication with orphan designation, must have an agreed paediatric study plan (PSP) in place (even if the adult indication does not occur in children) if the molecular target is substantially relevant to the growth or progression of a paediatric cancer. More drug developers will now need to consider the implications of PREA. In December 2019, the FDA issued a draft guidance to help companies comply with the new regulations (1).

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.

About the author

Lynne Georgopoulos, RN, MSHS, RAC, is Vice President of Regulatory Affairs and Pediatric Strategic Development at Synteract. She is responsible for providing professional leadership to ensure compliance with FDA, EMA, and ICH regulations in the creation and execution of preclinical, clinical, and regulatory strategies to support paediatric drug development across multiple therapeutic areas. She draws on 30- plus years in clinical operations/development, regulatory affairs, project management, and quality assurance with extensive R&D experience in small molecules and protein therapeutics, from investigational NDA to NDA/BLA.
Print this page
Send to a friend
Privacy statement
News and Press Releases

Merck Introduces Parteck® COAT Excipient, a Fast-Dissolving Material for Immediate Release Coating

• Designed to simplify the formulation and coating process for tablets • Optimized particle size leads to fast dissolving and increases coating process efficiency Merck has launched its Parteck® COAT excipient, a new functional material designed for immediate release film coating applications. Parteck® COAT is a particle engineered polyvinyl alcohol (PVA) with a unique particle structure that enables rapid dissolution even at low temperatures leading to an increased process efficiency.
More info >>

White Papers

Pandemic respiratory vaccine clinical trials: a departure from business as usual

ICON plc

Around the world, the “V” words are on everyone’s lips: Virus and Vaccines. In response to the urgent need for a vaccine for COVID-19, researchers are, at time of publication, running 500+ clinical trials (and counting) on a number of antivirals, antibodies and vaccines. Promising possibilities range from novel new drugs/vaccines, repurposing treatments currently indicated for HIV, Ebola and malaria, to monoclonal antibodies and immune serum.
More info >>

Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement