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A new drug delivers on restored function of oxygen-starved heart tissue in an animal model of global hypoxia

A new drug delivers on restored function of oxygen-starved heart tissue in an animal model of global hypoxia
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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. ....

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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. ....

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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. ....

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FDA Clarifies Approach To Pediatric Drug Development - Life Sciences, Biotechnology & Nanotechnology

On May 17, the U.S. Food & Drug Administration ("FDA") issued two important draft guidance documents, which clarify the agency's approach to requirements and incentives in the realm of pediatric drug development. ....

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