CLINICAL ROLE -
The European Medicines Agency: A Modern Robin Hood?
Many studies with a stated goal of advancing child health care in administratively-defined minors have no clinical value and may even harm young patients.
Pediatric Medication Studies: A New Challenge for Institutional Review Boards, Ethics Committees
Institutional review boards and ethics committees have seen it as their main task in the past few decades to protect children from questionable studies; however, they are faced with a new challenge with pediatric drug development.
Have Children Truly Ever Been ‘Therapeutic Orphans?’
Imposing the FDA on-label/off-label framework on administratively defined "children" resulted in a regulatory demand for pediatric studies that had no basis in clinical medicine, with the exception of the small group of preterm newborns.
Questionable Drug Studies in Minors Enforced by Regulatory Authorities
Pediatric drug development, which has a complex background and history, has fundamental catches based around how children are defined in the context of clinical studies.
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