BIO Comments on FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
August 3, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.
The draft guidance is an important step towards ensuring stakeholders understand FDA’s expectations regarding the inclusion of adolescents in clinical trials for oncology products. BIO asks the FDA to consider reviewing and discussing the draft guidance with other global health authorities during pediatric cluster calls and asks for educational efforts directed towards institutional review boards (IRBs), which will be critical for successful implementation of the draft guidance.
In addition, BIO asks for clarification on how the draft guidance relates to the Pediatrics Research Equity Act (PREA) and the FDA Reauthorization Act of 2017, Section 504, Development of Drugs and Biological Products for Pediatric Cancers. BIO requests case examples demonstrating circumstances in which adolescents have different physiology and/or psychology relative to adults. BIO’s comments include general suggestions as well as line edits.
Download Full Comments Below
BIO Letter Inclusion Of Adolescent Patients In Adult Concology Clinical Trials FDA–2018-D-1540
One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…
Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.
The draft guidance is an important step towards ensuring stakeholders understand FDA’s expectations regarding the inclusion of adolescents in clinical trials for oncology products. BIO asks the FDA to consider reviewing and discussing the draft guidance with other global health authorities during pediatric cluster calls and asks for educational efforts directed towards institutional review boards (IRBs), which will be critical for successful implementation of the draft guidance.
In addition, BIO asks for clarification on how the draft guidance relates to the Pediatrics Research Equity Act (PREA) and the FDA Reauthorization Act of 2017, Section 504, Development of Drugs and Biological Products for Pediatric Cancers. BIO requests case examples demonstrating circumstances in which adolescents have different physiology and/or psychology relative to adults. BIO’s comments include general suggestions as well as line edits.