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An overview of the legal requirements for children’s medicines that marketing authorisation holders (MAHs) need to abide by.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Stakeholders were consulted on how they felt access to pediatric TB drugs could be improved
Annual report on children and young people’s health from the Chief Medical Officer (CMO), Professor Dame Sally C Davies.
The importance of medicine safety and how to report side effects of medicines via the Yellow Card scheme is now part of the statutory guidance for schools in England.
As with any medicine, the MHRA will keep the safety and effectiveness of the adrenaline nasal spray under close review.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
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