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Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
Article in 'International Journal of Tuberculosis and Lung Disease'
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Annual report on children and young people’s health from the Chief Medical Officer (CMO), Professor Dame Sally C Davies.
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