Module232025

S11 Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals

For your consideration is also this topic:

E21 Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

E 7 Studies in support of special populations: Geriatrics

WHO guidance

Paediatric clinical trials guidance for assessors

EMA guidance The EMA space on paediatrics has an incredible amount of overview and detailed guidance and is highly recommended

EMA Product Class Waiver

IRIS guide for applicants

Paediatric investigation plans: Templates and forms

PIP Key Elements guidance

Policy on the determination of the condition(s) for a Paediatric Investigation Plan/Waiver (scope of the PIP/waiver)

Reflection paper on physical frailty: instruments for baseline characterisation of older populations in clinical trials - First version

Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling

Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling

Guideline on pharmaceutical development of medicines for paediatric use

Reflection Paper: formulations of choice for the paediatric population

Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications

FDA guidance FDA Draft Guidance: Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Guidance for Industry

FDA Draft Guidance: Rare Pediatric Disease Priority Review Vouchers

FDA Guidance: Nonclinical safety evaluation of pediatric drug products