BIO Comments on FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.
The draft guidance is an important step towards ensuring stakeholders understand FDA’s expectations regarding the inclusion of adolescents in clinical trials for oncology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 BIO asks the FDA to consider reviewing and discussing the draft guidance with other global health authorities during pediatric cluster calls and asks for educational efforts directed towards institutional review boards (IRBs), which will be critical for successful implementation of the draft guidance.
In addition, BIO asks for clarification on how the draft guidance relates to the Pediatrics Research Equity Act (PREA) and the FDA Reauthorization Act of 2017, Section 504, Development of Drugs and Biological Products for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
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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.
The draft guidance is an important step towards ensuring stakeholders understand FDA’s expectations regarding the inclusion of adolescents in clinical trials for oncology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 BIO asks the FDA to consider reviewing and discussing the draft guidance with other global health authorities during pediatric cluster calls and asks for educational efforts directed towards institutional review boards (IRBs), which will be critical for successful implementation of the draft guidance.
In addition, BIO asks for clarification on how the draft guidance relates to the Pediatrics Research Equity Act (PREA) and the FDA Reauthorization Act of 2017, Section 504, Development of Drugs and Biological Products for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.