regulatory approval

What Are the Challenges in Regulatory Approval for Neonatal Disorders?

Regulatory approval for neonatal disorders faces unique challenges:
- Limited Study Populations: Recruiting sufficient numbers of neonates for clinical trials can be difficult.
- Ethical Concerns: Conducting research in this vulnerable population requires stringent ethical considerations.
- Specialized Protocols: Neonates have different physiological characteristics that necessitate specialized research protocols.

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