Module232025

12/05/2025

Examples of Regulatory Guidance and Documents Indicating the Acceptability of Including Adolescents and Older Children in Adult Clinical Trials

Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients

Jul 2020

https://www.fda.gov/media/121318/download

Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs (draft)

Jun 2019

https://www.fda.gov/media/127712/download

Pediatric HIV Infection: Drug Product Development for Treatment

Mar 2019

https://www.fda.gov/media/113319/download

Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

Mar 2019

https://www.fda.gov/media/113499/download

Rare Diseases: Considerations for the Development of Drugs and Biological Products

Dec 2023

https://www.fda.gov/media/119757/download

S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines

Sep 2018

https://www.fda.gov/media/101398/download

Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

Mar 2022

https://www.fda.gov/media/115172/download

E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population (2018)

Apr 2018

https://www.fda.gov/media/101398/download

Uncomplicated Gonorrhea: Developing Drugs for Treatment

Aug 2015

https://www.fda.gov/media/88904/download

General Clinical Pharmacology Considerations for Pediatric Studies

Dec 2014

https://www.fda.gov/media/90358/download

Influenza: Developing Drugs for Treatment and/or Prophylaxis

Apr 2011

https://www.fda.gov/media/73339/download

https://database.ich.org/sites/default/files/ICH_E1 1A_Guideline_Step4_2024_0821.pdf

E11A Clinical Investigation of Medicinal Products in the Pediatric Population (2024)

Aug 2024

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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Acknowledgement I would like to express my deepest appreciation and gratitude to Dr. Anne Behringer for her support for the preparation of this presentation

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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